Pure mRNA: Downstream processing strategies for an emerging modality
According to industry experts, the purification step is absolutely essential to the commercialization of any mRNA therapeutic. As the field of mRNA therapeutics advances, there is now a growing focus on refining, optimizing, and standardizing manufacturing processes, particularly the downstream processing steps. This phase is crucial for ensuring that any mRNA product is pure, stable, and effective.
Key differences between mRNA and more traditional biologics necessitate specialized purification methods to remove impurities and meet still-emerging quality standards. The efficiency and scalability of these processes could make or break the successful commercialization of current and future mRNA therapies. Download this resource to stay on the cutting edge of mRNA therapeutic development and manufacturing.
Establish the importance of mRNA purification, Explore challenges unique to this new modality, Examine the range of purification tools available to current or aspiring manufacturers of mRNA therapeutics
Establishing a carbon-free and recycling-oriented society: Recycled Plastic Analysis Solutions
Various plastic recycling measures are being implemented in response to growing awareness about needing to establish a carbon-free and recycling-oriented society. Plastic recycling primarily involves one of these two processes: "material recycling," which uses waste plastic directly in the form of plastic as a raw material for reuse products, and "chemical recycling," which chemically decomposes waste plastic for reuse as a raw material in new products.
In this eBook, we highlight our analytical solutions, including structural analysis, mechanical properties, impurities analysis, and multifaceted evaluations used in the plastic recycling process.
Grasp an overview of analysis solutions for plastic recycle processes (Structural Analysis, Mechanical Analysis, Impurities Analysis, Multifaced Evaluation) as well as instrument used for tackling challenges in plastic recycling., Discover the importance of comprehensive evaluation in plastic analysis and learn about the range of instrument that addresses these critical issues., Gain insights into essential instruments for process management and quality control.
Nitrosamines Analysis: Solutions for Risk Management and Analytical Testing from Experienced Industry Leaders
Given stringent regulatory guidelines regarding the presence of nitrosamines, drug innovators and manufacturers must consider control of these impurities not only in the active pharmaceutical ingredient (API) chemical process, but also in their starting materials, solvents, and more. A plan for control early in development is critical to maintaining product quality and safety. Partnering with the right CDMO can help mitigate risk throughout the process.
Definition/overview of nitrosamines, Risk assessment for the potential formation of nitrosamines, Development and validation of analytical methodology, Analytical considerations
Improving Solubility: Stabilizing the Amorphous State
Amorphous materials, known for improving solubility and dissolution rates, face stability challenges, losing their beneficial properties. Stabilizing these materials in a polymer matrix through amorphous solid dispersions helps retain their advantages. By embedding active ingredients in polymers, the stability and solubility are enhanced, with formulation optimization achieved by adjusting solvents, drug loads, and temperature profiles. Polymers also exhibit different thermal behaviors, such as LCST (Lower Critical Solution Temperature), which are important for developing controlled drug delivery systems. Automated systems, such as the Crystal16® , enhance efficiency in drug formulation by determining solubility curves and dissolution rates through transmissivity measurements, which also help identify key processes like micelle formation.
Understand how amorphous materials improve drug solubility and the need for stabilization in polymer matrices., Learn how polymer thermal behaviors, including UCST and LCST, impact drug delivery systems, with a focus on materials like PEG and polyoxazoline, which exhibit inverse solubility behavior at higher temperatures., Explore the use of transmissivity in tracking micelle formation, with low transmission indicating undissolved particles and an increase to 70% marking micelle formation., Recognize the benefits of using automated systems, such as the Crystal16®, for efficient solubility testing, dissolution rate analysis, and reproducible results in drug formulation.
Quality innovations in monoclonal antibody manufacturing
Antibody therapeutics provide cell-specific recognition customized for a patient. They offer the ability to treat cancers and autoimmune diseases with fewer side effects than traditional treatments such as chemotherapy. As the scientific understanding of traditional monoclonal antibody therapeutics has advanced, researchers have moved into engineering proteins to create next-generation antibody modalities.
This e-book explores solutions for common purification, analysis, and quality evaluation challenges when manufacturing modern antibody-derived therapies. Tools such as affinity chromatography, quantitative polymerase chain reaction (qPCR), and single-domain antibodies provide effective and flexible solutions for improving the efficiency and reliability of antibody biomanufacturing practices.
Affinity purification for monoclonal antibody manufacturing, Using quantitative PCR to test for residual DNA from biomanufacturing processes, Innovative uses of single-domain antibodies in monoclonal therapeutic research and development
Sustainable Solutions for the Global Food Crisis
As the global population continues to grow, traditional farming alone is not sufficient to satisfy the rising food demand. Therefore, the need for sustainable food production becomes more critical than ever. Currently, there are several promising alternative and plant-based food sources derived from insects, cultured meat, fungi, algae, lentils, peas, soybeans, oats, and more.
In our whitepaper, we explore innovative strategies to address the growing need for food while reducing environmental impact. We delve into alternative food sources that excel in flavor, availability, sustainability, cost-effectiveness, and nutrient composition and the key analytical innovations needed to bring them to market.
Explore the need for sustainable food production due to global population growth and limitations of traditional farming., Examine various alternative food sources such as insects, cultured meat, fungi, algae, and plant-based options., Understand the attributes of alternative foods, including flavor, availability, sustainability, cost-effectiveness, and nutrient composition., Delve into the role of analytical technology in developing and optimizing alternative food sources.
Mitigation of PFAS in Drinking Water Through Analytical Innovation
Per- and polyfluoroalkyl substances (PFAS) have recently gained significant attention as an emerging threat. As a result, the EPA has developed a regulatory strategy to address PFAS contamination in drinking water. To keep up with regulatory requirements, there are analytical challenges that require highly sensitive mass spectrometers or sample preparation techniques, such as solid phase extraction coupled with LC/MS/MS, as implemented in EPA Method 537.1 and 533.
In this whitepaper, discover key insights into United States regulatory requirements and the latest analytical innovations to optimize PFAS analysis, as required by the Environmental Protection Agency (EPA) Methods 533 and 537.1 as well as emerging methods in non-potable water matrices such as Method 1633.
Uncover the latest EPA regulatory requirements for PFAS analysis in drinking water, Discover an innovative method for optimizing PFAS analysis, Maximize uptime with low maintenance LC/MS/MS instrumetnation
The Meteoric Rise of Solid-State Batteries: Innovations and Analytical Instrument Breakthroughs
All solid-state battery (ASSB) technology, defined as having only solid components, will unlock materials chemistry limitations from traditional battery technologies and enable alternative activities and advanced designs. The costs of battery manufacturing are trending down, and energy density is trending up, however, this trend is plateauing. This plateau in energy density and cost efficiency offers a perfect opportunity for new battery innovations and ASSBs stand to be the primary battery system of the future.
In this whitepaper, we will look at the factors that need to be overcome by ASSB developers in order to dominant the battery landscape, as well as the newest ASSBs designs, innovations and analytical equipment considerations to support ASSBs' meteoric breakthrough into the battery landscape.
Understand the key factors and trends that are influencing the future of the battery industry, Discover how scientists are unlocking chemistry limitations from traditional battery technologies and enabling solid-state batteries to break through the current energy density plateau, Learn and overcome battery failure, cell dimensional changes, and cell breathing issues, Discover the analytical technologies and techniques used to develop revolutionary innovations in electrolyte, anode, and cathode components in solid-state batteries.
Better Chemical R&D Data Management: The Expressway to Market Success
In the fast-paced world of specialty chemicals and formulation development, leading organizations need to leverage every tool available to speed up their journey to market success while reducing risk. Here, we explore how electronic laboratory notebooks, data visualization and predictive analytics software, and a chemical structure search tool can revolutionize R&D workflows.
Increase efficiencies by recording experiments in a common digital platform, Implement leading data management techniques for real-time analysis, Transform data into valuable chemical product development insights
Overcoming Lithium-Ion Battery Obstacles for the Alternative Energy Revolution
Global climate initiatives and increase demand for battery reliant technological innovations are driving the alternative energy revolution. Rapidly emerging as a cornerstone technology in this revolution are lithium-ion batteries, capable of providing key energy advantages to enable innovations in the energy, automotive, and tech sectors. In this white paper, learn about the two major obstacles facing the LIB industry and the solutions being used to overcome them and stay ahead of the competition.
Understand underlying issues that can contribute to battery failure and thermal runaway, Explore the environmental, social, and logistical challenges in raw material acquisition, Learn about the ideal technologies and methods for off-gas monitoring across various profiles, Examine the recycling process and analytical challenges of repurposing LIBs
Transition GC/MS instruments to hydrogen without compromising performance
Recent helium shortages have become acute in many regions, resulting in price increases, and even stopped shipments. These shortages jeopardize the operations of labs that depend on gas chromatography. Hydrogen (H2) being a low-cost and easy to procure gas is a good alternative to helium. However, owing to its non-inert nature, it causes unwanted reactions in the MS source.
The Agilent HydroInert source addresses this problem and is ideal for labs that are considering hydrogen but are worried about analytical limitations.
HydroInert allows you to:
• Prevent work stoppages caused by insufficient helium supplies
• Reduce sensitivity loss and spectral anomalies
• Achieve faster, shorter separations
• Minimize downtime caused by system maintenance and ion source cleaning
In this collection of app notes, you will learn about resources from Agilent to ease the transition from helium to hydrogen, allowing GC/MS labs uninterrupted operations.
HydroInert source performance for classes of chemicals that typically react with hydrogen carrier gas, Measuring PAHs and volatile organic compounds using the HydroInert source and hydrogen carrier gas
10 common questions when upgrading chromatography data management systems
System upgrades keep instruments up to date, provide new features and functionality, and address data security vulnerabilities. But when upgrading frequently used instruments, such as chromatography equipment, practical challenges come with the benefits. Lab managers have to choose an upgrade approach, collaborate with their organization’s IT department, and manage regular lab operations during the transition. Here are answers to 10 common questions about the process of a chromatography data system (CDS) upgrade.
Understand the benefits of upgrading a CDS, Understand the major considerations involved in an upgrade, Explore the options available for an upgrade, Learn about tools and resources that can make an upgrade as simple as possible
Automated Monoclonal Antibody Subunit Analysis by Online Reduction Using 2D-LC/MS
Recombinant monoclonal antibodies (mAbs) have become a popular class of biotherapeutics over recent years. Subunit analysis is a possible strategy to assess critical quality attributes in mAb products.
This application note describes a fully automated workflow for the purification, online reduction, and mass spectrometry (MS) analysis of mAb subunits using two-dimensional liquid chromatography (2D-LC).
Reducing disulfide bonds divides mAbs into heavy and light chain subunits, 2D-LC can be operated with a trap column, allowing online reduction, MS-compatible SEC can desalt and separate mAb subunits
Home soy-weet home
Soy-based household products are more common than you might think. Whether it is in printing inks, foams for furniture, or skincare products, soy offers both sustainability and performance. Learn the fascinating stories and science behind soy-based goods, including:
What soy ink is made of and how it became a staple of the printing industry., Why changes in the mattress industry have created an opportunity for a new generation of environmentally friendly beds., How soy-based skincare products reduce wrinkles and promote healthy-looking skin.
Affinity chromatography solutions for commercial adeno-associated virus manufacturing
Gene therapy has been hailed as a revolutionary approach to prevent or treat diseases ranging from inherited disorders to cancer. One way to deliver DNA therapy to a patient’s cells is using viruses that do not cause disease in humans. Adeno-associated viruses (AAVs) are the viral carriers of choice for many gene therapy applications due to their history of low immunogenicity and good clinical outcomes for patients.
AAV are produced commercially in mammalian and insect cells, which means scalable, efficient purification strategies are critical to meeting quality standards and clinical demand. Affinity chromatography resins designed to broadly capture AAVs, or capture AAV subtypes, provide solutions to help manufacturers overcome purification bottlenecks. Affinity resins that capture non-target viruses can also clear contaminants to ensure AAV products meet clinical purity standards. With efficient processes in place, biomanufacturers can ensure that AAV production does not hinder the pace of gene therapy development.
Why efficient purification solutions are needed in the AAV manufacturing and gene therapy field, How affinity ligands enable specific capture and purification of varied subtypes of AAV, How affinity ligands speed steps to clear contamination from non-target viruses and meet quality standards
How affinity tags are speeding up malaria vaccine development
The parasite that causes malaria has no clear biological target for researchers to target with a vaccine. Despite decades of development, only one malaria vaccine to date has been approved by the World Health Organization.
Researchers have a pipeline of malaria vaccine candidates in development and clinical trials. Antigens for each vaccine are manufactured using the same blueprint, which includes using a novel purification approach for a biotherapeutic: affinity chromatography.
Producing each antigen with the same affinity tag has enabled the team to streamline purification, keep costs down, and rapidly advance their vaccine candidates into the clinic.
How affinity tags can be used to manufacture biotherapeutics for challenging targets, such as malaria vaccines, A string of four amino acids, called a C-tag, can be attached to engineered biomolecules and used as a platform technology to accelerate vaccine development, The C-tag affinity system is a viable technology to produce vaccines compliant with good manufacturing practices
Pure and simple: Affinity chromatography solutions for complex biotherapeutic manufacturing
Biotherapeutics are a rapidly expanding class of drugs, yet manufacturing challenges may limit their clinical impact. This eBook explores how affinity chromatography can offer a viable solution to help accelerate biomanufacturing and ensure biotherapeutic production meets demand.
Biotherapeutic producers face many challenges that can create bottlenecks during the manufacturing process. In this eBook, learn how affinity chromatography can provide a viable solution to overcoming these challenges., Biotherapeutic modalities are varied, which can make a one-size-fits-all approach to purification challenging. Learn more on affinity resins that have been designed to facilitate manufacturing of antibodies, vaccines, mRNA, and viral vectors., Due to the diversity and speed of modern biopharmaceutical development, commercially available affinity resins may not always be viable options. This eBook describes how custom affinity resins can be fine-tuned to target virtually any molecule, expanding
Advancing drug development using in silico modeling
Predictive modeling has the potential to aid in developing robust drug development and manufacturing platforms. However, realizing the full potential of the technology requires careful selection and application of in silico strategies and a deep understanding of how to interpret and derive the most valuable insights from the data. This report provides a framework for that understanding by outlining some of the processes that stand to gain the most from computational modeling and identifying the in silico capabilities that can be used to accelerate and de-risk each phase of development.
Some of the key modeling capabilities that will be discussed include:
·Predictive modeling for solubility and bioavailability enhancement
·Accelerated stability modeling for shelf life and packaging determination
·Materials science, compaction simulation, and process modeling
·ADME-PK modeling to predict the effect of API physicochemical properties and pharmacokinetics
Understand some of the processes in drug development that can gain the most from computational modeling, Determine applications of in silico strategies, Identify which in silico capabilities that can be used to accelerate and de-risk in each phase of development
In pursuit of polymers that can protect the planet
The steady stream of plastic production and consumption poses one of humanity’s biggest sustainability challenges, filling the seas and soil with waste that will take millennia to degrade. But a new generation of chemists is rising to meet this challenge.
This whitepaper will look at some of the innovative research that can help make future plastic products more environmentally friendly and reusable, and reverse the accumulation of harmful polymer byproducts.
‘Upcycling’ strategies that can turn plastic waste into useful polymers for making new products, Plant-derived polymers that can dramatically cut down on petroleum consumption without any compromise in quality, Polymers that efficiently extract toxic ‘forever chemicals’ from out of the water supply
Managing purity in vaccines: How advanced purification technologies are speeding the hunt for new protections against disease
By now, artificial intelligence-enabled tools should’ve begun helping us develop our understanding of cause-and-effect relationships between ingredients and technical or functional performance. But it’s going more slowly, and with spottier results, than many had hoped.
Why is it taking so long to realize? And what can companies be doing today to articulate and scale their AI strategy?
The importance and challenges of science-based product development, Why actionable artificial intelligence remains elusive in the applied sciences, Why lab data capture infrastructure is critical to achieving positive outcomes through AI — and how so many get it wrong, The path to become AI-enabled for applied science companies
Addressing challenges across the virus like particle manufacturing workflow
Virus like particles are a powerful platform to generate highly immunogenic vaccines, particularly for viruses that are mutating frequently. These particles are made from viral proteins that self-assemble into a structure resembling a virus’s outer shell. Vaccines based on virus like particles for hepatitis B and human papillomavirus are available commercially.
An integrated system of tools for protein expression, purification, and quality control testing can help support efficient and cost-effective virus like particle production on a commercial scale.
Baculovirus-based protein expression systems offer a flexible platform for generating virus-like particles, Affinity-based capture techniques can speed purification and polishing steps, Quantitative detection of nucleic acids can be used for biotherapeutic quality control testing
Beyond a Drawing Tool: The Evolution of a Comprehensive, Chemically-Intelligent Solution for Chemistry Communication
As the world moves towards increased automation, electronic record-keeping, and cloud connectivity, there is also significant innovation in communication tools. For chemists, these innovations bring about revolutionary changes in how they share their research.
Learn how innovative software can empower today’s chemists to search, reuse, and report their ChemDraw data efficiently and seamlessly. This whitepaper delves into the current communication struggles in chemistry research and how they can be easily overcome with purpose-built, innovative software.
How to overcome the lack of efficiency in conducting admin tasks and navigating siloed reporting applications and databases., How to easily search and find chemical data buried deep in your files. ChemOffice+ lets you extract and reuse existing chemical content from old ChemDraw files stored inside MS Word, PowerPoint, and SD files without having to open them., How to automatically generate consistently formatted reports and make your chemistry more visually compelling and easier to follow.
ChemDraw and Chemoffice+ Cloud tips and tricks v21
This is an interactive ChemDraw and ChemOffice+ Cloud v21 Tips & Tricks eBook that highlights hidden gems that have been part of ChemDraw for a long time and new tips that empower Chemists to draw more efficiently, communicate their research visually, and expedite mundane tasks such as managing molecules and reactions as well as everyday reporting.
Learn the new Shortcuts on ChemDraw, Learn how bring your molecules to life, Learn how drawing is literally as easy as 1,2,3
Solid-Core Particles: Application to Small Molecule LC Analysis
The current generation of solid core particles for LC analysis were introduced in 2006 and provide higher efficiency separations than equivalently sized fully porous particles. Since then, their use for the analysis of both small and large molecules has increased steadily, in a wide variety of analytical fields, to drive high performance separations and increases in laboratory throughput. This white paper focusses on the application of solid core particles to small molecule analysis. It begins by introducing the concept of solid core particles, their morphology, history of development and current methods of synthesis, before moving on to discuss the theory behind the performance advantages they offer. Finally, example applications that demonstrate how these particles can be used to provide solutions for some of the analytical challenges faced by the modern chromatography laboratory are discussed.
Learn how to apply solid-core particles to small molecule analyses, Learn the performance advantages of solid-core particles, Review example solid-core small molecule applications
LC Chromatography Troubleshooting
High pressure liquid chromatography (HPLC) is a benchmark technique used in laboratories across the world. However, even experienced analysts that are familiar with HPLC concepts and principles can fall victim to chromatographic pitfalls that arise. Some common issues include misshapen peaks, unstable baselines, problems with reproducibility,and the observance of irregular back pressure. Identifying and correcting these problems quickly can not only save time but increase productivity in the lab. Chromatographic issues can arise from any part of the system, including the pump, autosampler, column oven, or detector, and each component of the system must be considered individually.
Learn how to identify and solve many common LC issues that can arise, Learn preventative maintenance measures for their LC systems
Advances in Food Testing & Environmental Analysis Compendium
This application compendium contains a collection of environmental and food testing application notes demonstrating the low detection levels and sensitivity of the Agilent Triple Quadrupole GC/MS systems for the quantitation of pesticides, volatile and semi volatile compounds to include:
-Estimation of Ethylene Oxide and Ethylene Chlorohydrin in Sesame Seeds Usingn Agilent 8890 GC and 7000D Triple Quadrupole MS System
-Low Calibration Limit Research for Multiresidue Pesticides in Milk Using the Agilent 8890/7010B and 7890B/7000C Triple Quadrupole GC/MS Systems
-Use of Salt to Increase Analyte Concentration in SPME Headspace Applications
-Analysis of Free Volatile Phenols in Smoke-Impacted Wines by SPME
-Analysis of 1,4-dioxane in Water by Purge and Trap
A reliable analytical method for the determination of 2-MCPD and 3-MCPD fatty acid esters in infant formula method to determine 1,4-dioxane in consumer products including: cosmetic, personal care, and cleaning products., Demonstrate the 8697headspace sampler is an excellent means of introducing VOCs trapped in soils and sediments to GC for identification and quantitation., DVB/carbon WR/PDMS SPME Arrow (1.1 mm) demonstrates the significant benefit in extraction efficiency due to its larger sorption phase volume.
Online Reaction Monitoring of Aspirin Hydrolysis
In modern production of small molecule pharmaceuticals and biopharmaceuticals, the reaction must be closely monitored and potentially even controlled by online reaction monitoring analytics.
This application note demonstrates the use of the Agilent InfinityLab Online LC Solution for monitoring reactions with different reaction speeds. The method requires high sampling speeds for sampling and quenching, as well as direct injection for the fastest results. As a model reaction, the pH-dependent hydrolysis of acetylsalicylic acid (Aspirin) to salicylic acid has been used.
How to set up the HPLC instrument for an online LC experiment, How to set up the Agilent Online LC Monitoring Software to orchestrate the experiment, How to display experimental results in the Online LC Monitoring Software
Automated Switching Between Peptide and Glycan Mapping
Glycan and peptide mapping are key analytical methodologies for the structural characterization of therapeutic proteins such as monoclonal antibodies (mAbs). This application note describes glycan and peptide mapping of mAbs performed on the same system without manual intervention upon switching between modes. The instrumental setup offers great flexibility and productivity for performing glycan and peptide mapping in one single analytical sequence. Highly informative and precise data is obtained in the analysis of originator and biosimilar mAbs.
How to achieve rapid glycan release and labeling, How to switch between glycan and peptide mapping without manual intervention, How to switch between glycan and peptide mapping without manual intervention
Analyzing lipid nanoparticle composition using liquid chromatography
Lipid nanoparticles (LNPs) have emerged as promising delivery vehicles for nucleic acids in the pharmaceutical industry. To ensure safety and efficacy of the final drug product, the lipid components need analytical characterization of composition, ratio, and degradation.
The Agilent 1290 Infinity II Bio LC enables you to do just that. Download this application demonstrating the analysis of the lipid components of patisaran (trade name Onpattro). Optimal separation of the four LNP components with excellent peak shapes, precision, and sensitivity was achieved.
Composition and structure of LNPs, How to achieve best LC separation for the LNP components, How to use the Evaporative light-scattering detection for universal detection
Isolation of Green Tea Catechins Using Preparative HPLC
Tea is not only one of the most widely consumed beverages in the world—its high antioxidant content also makes it the beverage most believed to have health-promoting effects.
This application demonstrates the isolation of catechins, the most important group of antioxidants in green tea. Despite the complex composition of green tea, five catechins collected had purity of 95% or higher.
Separate green tea extract by reversed-phase LC/MS, Use a fraction collector to isolate single compounds, Trigger fraction collection by MS signal for highest selectivity, Reanalyze fractions to assess purity and gain basic structural information
The Grass Is Greener: Exploring the Promise of Soy as a Chemical Feedstock
The chemicals in nearly every modern manufactured item can be traced back to an oil or natural gas well. But that is changing. In the search for more renewable and sustainable sources of chemicals, soybeans are emerging as a versatile and abundant chemical feedstock. Already, soybean-derived adhesives and plastics are showing up in products as diverse as kitchen cabinets and artificial turfs. Download the ebook to learn how soybeans are replacing petrochemicals in everyday products.
Soybean protein and oil are versatile feedstocks that can be applied in a range of different product types. Also, because plants can be engineered or bred to have certain characteristics, the chemical composition of soybean oil can be adjusted for differe, Among crops, soybeans are globally abundant and require less fertilizer because they return nitrogen to the soil, making them a sustainable and abundant chemical feedstock., Using soybeans as a source of chemicals has a long history, but new perspectives on safety and chemical innovations are now driving the development of more diverse applications.
Exploring deep chemical space: A new frontier for catalysts
Synthetic chemists rely heavily on a small number of transformation types when planning synthetic routes. The knock-on effect is that they have only explored a few pockets of chemical space. New catalytic innovations will enable them to search further than ever before.
These catalysts may lead to areas of chemical space populated with molecules that can be used as universal cures for cancer, ones that can stop a pandemic in its tracks, or a high-performance polymer that somehow knows to decompose immediately after use.
Synthetic chemists are creatures of habit that rely heavily on a handful of reaction types including amide bond formations and carbon-carbon bond formations., Chemical space is estimated to contain more stable molecules with drug-like properties than there are in the solar system. So far, only just over 110 million have been synthesized and they are bunched together in just a few regions of chemical space., New catalytic innovations will enable chemists to search further into chemical space than ever before for molecules with useful properties., The catalytic potential of bismuth, nickel and iron are currently under the microscope.
Thermal Degradation Studies on PLA Sample (TG-FTIR)
Purification and quality control solutions to accelerate vaccine development
Vaccines are critical for disease protection. Rapid vaccine development will be important to respond to new and emerging diseases, as demonstrated by the COVID-19 pandemic caused by SARS-CoV-2. In the past decade, new vaccine types have been developed and can be adapted for use against numerous diseases. However, each type comes with its own manufacturing challenges. Developing versatile purification and quality control methods can help overcome these challenges and meet global demand for vaccines of all types.
Affinity and non-affinity chromatography resins are critical to achieving the high purity and yield needed to produce effective and ample vaccines. Affinity resins developed based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies can improve selectivity in vaccine purification protocols. Having a varied suite of non-affinity resins can further improve purity and yield. Furthermore, the development of rapid and accurate quality control assessments can ensure vaccine components are sufficiently pure throughout the manufacturing process, thus improving process design. This whitepaper from Thermo Fisher Scientific highlights how the combination of versatile chromatography resins and quality control assessments can accelerate vaccine manufacturing processes.
Why affinity and non-affinity chromatography are important for vaccine purification and production, How choice of chromatography resin can influence the manufacturing process, Why quality control measures are critical for ensuring vaccine safety and efficacy , How rapid and accurate quality control assessments can help accelerate vaccine development and production
Reaching The Next Frontier Of The Chemical Industry With Digital Transformation
The chemical industry relies on innovation to drive growth and change. Yet recent market trends coupled with advancements in technology and rapidly evolving customer demands have prompted chemical companies to re-think their approach to product development and call for creative solutions. Digital tools are one solution to getting the most out of the current technological moment and spurring innovation of chemical products.
Over the past decade, digital tools have evolved to become more useful and accessible to the chemical industry. Cloud-based electronic lab notebooks and data analysis software, among others, can help chemists seamlessly collaborate and get the most out of their data. This eBook from PerkinElmer describes how digital transformation – the adoption and integration of digital tools across an organization’s operation – can push the chemical industry into the future, helping to ensure that companies can meet world chemical needs today and in the years to come.
Why and how digital tools can push innovation in the chemical sciences, How cloud-enabled laboratory notebooks and data sharing can break down data silos, facilitate data reuse, and enable easy communication between team members, How chemically-smart software can aid data analysis to help research and product teams identify promising products
ChemDraw and ChemOffice+ Cloud Tips & Tricks
here are many improvements to be made to chemical drawing and the way chemists communicate with one another. ChemDraw’s innovative capabilities help chemists work more efficiently, communicate their research more clearly, and reach crucial information faster.
Uncover hidden gems that have been part of ChemDraw for a long time and learn about new tips that will empower you to draw more efficiently, communicate your research visually, and expedite mundane tasks such as managing molecules and reactions as well as everyday reporting.
Find and organize your chemistry to produce lists of compounds and slides for easier reporting, Perform quick structure searches in all documents where chemical information is stored, Create collections of select chemical structure drawings and their associated properties, Draw complex reaction schemes without touching the mouse with Hotkeys & Shortcuts, Make your chemistry stand out with Atom/Bond/Ring coloring and 3D display
6 essentials to get more out of your FT-IR instruments
In this whitepaper, learn more about the high performance FT-IR measurements in all three ranges of the infrared spectrum
6 essential capabilities that of FT - IR spectrometers that maximize productivity, sampling flexibility and collaboration Applications of tri - range FT - IR - from analysis of fast reaction kinetics to method development in pharmaceuticals and raw materi
Solutions for the LC-MS/MS determination of nitrosamine impurities in pharmaceutical API’s and addressing issues associated with DMF and NDMA co-elution
The detection and quantification of nitrosamine impurities in pharmaceutical materials has become a topic of global concern in recent years. Nitrosamine analysis is challenging and requires the application of highly selective and sensitive analytical techniques, capable of quantification in the low ppb range. This white paper discusses how LC-MS/MS methods can be developed and applied to the determination of a range of nitrosamine impurities, highlighted by regulatory authorities, in pharmaceutical APIs.
Additionally, the impact of isobaric interference from N,N-dimethylformamide (DMF), which may co-elute with and result in over-quantification of NDMA, is assessed. Varying the LC stationary phase chemistry to improve chromatographic retention and resolution of NDMA and DMF, along with considered selection of appropriate MRM transitions, was found to provide a solution to improve NDMA quantification accuracy.
Why nitrosamine analysis is important, How to detect and quantify nitrosamines impurities by LC-MS/MS., Strategies to avoid interference from other low molecular weight trace impurities, such as DMF.
Selecting a Column Geometry and Particle Size for Your Method and Instrument
Customers often ask how to decide which column size (length, ID, particle size) to use or which size to purchase for a new method development project. Such a decision can be made easier if you think about what you’d like to accomplish, and if you have some ways of making that decision more accurately, so that you ensure you will be successful. In this white paper, we will discuss some useful calculations that will help you choose a column that will be fit for your desired purpose.
To match your desired column geometry and particle size with your instrument’s pressure limit and extracolumn dispersion, how to estimate column pressure, how to estimate extracolumn dispersion and volume, To use an online tool to determine which stationary phases are most similar and most orthogonal (dissimilar) to a given column, To get the most performance from highly efficient, low-volume columns
HILIC Analysis for Polar Modifications of Proteins and Peptides
Post-translational modifications (PTMs) occur for proteins intended for both intracellular and extracellular functions. These biochemical changes to a protein can be enzymatic or non-enzymatic and may involve changes to amino acids' side-chain functional groups and their N-termini, as well as peptide hydrolysis. Many PTMs are polar by their nature, including glycosylation, deamidation, and oxidation.
These types of polar modifications are more readily analyzed (as released species or as modified proteins) using hydrophilic interaction liquid chromatography (HILIC) because they are retained and resolved better compared to reversed-phase liquid chromatography (RPLC).
In this white paper we investigate the characterization of glycosylation, deamidation, and oxidation as different types of PTMs
Learn why measuring and monitoring post-translational modifications are critical to assessing and maintaining the function and form of biotherapeutics, Review glycosylation, deamidation, and oxidation of proteins and peptides, Review examples of glycovariants and analysis of site occupancy using HILIC
Improving the purification of modern biotherapeutics with antibody-based affinity chromatography
Diversity of single-domain antibodies for purification of biotherapeutics and analytical assays
Biotherapeutics have a successful record for treating diseases and account for almost half of new drug approvals in the U.S. These therapeutics are produced in biological systems and thus present unique manufacturing challenges to achieve the yield and purity needed for an efficacious and safe treatment. Affinity ligands, which are designed to target a specific molecule, are commonly used during the biotherapeutic manufacturing pipeline to both capture and analyze the target molecule.
In recent years, biotherapeutic versatility has expanded. Manufacturing and analytical processes need to be tailored to each individual biotherapeutic, which can be challenging because not all molecules have established or commercially available chromatography resins. Development of affinity chromatography resins, including those based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies, have helped improve protocols for biotherapeutic development and manufacturing. This whitepaper from Thermo Fisher Scientific highlights the versatility of these affinity ligands and explores how they can support the development of diverse biotherapeutics.
Why affinity chromatography is important in the production of biotherapeutics , How decisions around affinity ligands can affect the manufacturing and analytical process, How affinity ligands can facilitate the purification and development of diverse biotherapeutics, How affinity ligands enable analytical methods that aid in biotherapeutic development
Custom chromatography solutions for complex biotherapeutics
Historically, antibodies have dominated the biotherapeutic market but today newer drug types like proteins, viral vectors, and cell therapies are arriving in the clinic in ever increasing numbers. This growth of non-antibody biotherapeutics is exposing gaps in the chromatography product range on the market. Customization enables a resin to be designed to match the specific performance requirements for the biotherapeutic being purified.
Customization is an option for the purification of novel biotherapeutics for which no off-the-shelf solution is available., Customized options exist for affinity chromatography, ion-exchange chromatography, and hydrophobic-interaction chromatography resins., Custom-resin development is a stepwise process, with vendors allowing the option to stop or pause resin development at various points.
Choosing a Chromatography Resin for the Downstream Purification of Biotherapeutics
Biotherapeutics can be used to treat numerous diseases and made headlines in the midst of the COVID-19 pandemic as a potentially life-saving treatment against SARS-CoV-2 infection. Market analysis suggests that global demand for biotherapeutic products will continue to increase at a rate that exceeds companies’ current manufacturing capabilities. Because biotherapeutics are produced in complex biological systems, efficient purification strategies are critical to overcoming manufacturing limitations and meeting the needs of patients.
The development of versatile affinity and non-affinity resins is important to improving biotherapeutic manufacturing. Affinity chromatography resins based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies can provide high selective affinity for a broad range of biotherapeutic targets, thus improving purification protocols. Likewise, varied non-affinity resins can further improve biotherapeutic purification and yield. This whitepaper from Thermo Fisher Scientific highlights the versatility of affinity and non-affinity resins and explores how they can support purification of diverse biotherapeutics.
Why affinity and non-affinity chromatography are important for the purification of biotherapeutics , How affinity ligands enable specific capture and purification of varied types of biotherapeutics, How decisions around selecting a non-affinity ligand can affect the purification and manufacturing process
Atomic force microscopy covers the landscape of polymer characterization
Atomic Force Microscopy is a powerful technique for analyzing materials at the nanoscale. Through a variety of different modes, AFM can analyze a wide range of chemical, mechanical and even electrical properties across an extensive variety of materials. This whitepaper reviews the many ways that materials scientists can use AFM to examine polymers’ structure and properties at the microscopic level for a more complete understanding of the material.
Common AFM modes used to characterize polymers and polymer composites, Practical considerations for AFM on polymer samples, including tip selection and sample preparation Applications of AFM in characterizing polymers’ mechanical properties, Specialized modes for in-depth analysis of viscoelasticity, electrical properties and chemistry
Best Practices for Limiting Hazardous Solvent Exposure with Safety Caps and Waste Containment for HPLC and UHPLC Systems
This white paper will discusses the impact of harmful solvent evaporation in liquid chromatography labs, which puts the lab personnel risk. Readers will be presented with a solution to limit the evaporation of harmful solvents into the lab, and therefore limit the exposure of these toxic solvents to the laboratory personnel.
Learn how solvent evaporation can affect their chromatography, Review examples of a safety cap solution that will all but eliminate solvent evaporation in liquid chromatography lab, Learn how hazardous solvent evaporation can affect lab personnel over time
Analysis of Hand Sanitizers to Support Label Claims
At the height of the first wave of the COVID-19 pandemic, consumers around the world experienced a supply shortage related to alcohol-based hand sanitizer. As new producers entered the market, and existing manufacturers sought to ramp-up production to meet the growing demand, lower grades of ethanol and isopropanol (IPA) started to appear on the market. To ensure the safety and efficacy of hand sanitizer products, it is recommended that manufacturers test their products to ensure appropriate levels of active ingredients, as well as a means of ensuring label-claim accuracy. In this application note, an efficient and simple, “dilute and shoot” method for the analysis of IPA and ethanol in hand sanitizer products is detailed. With a run-time of only 5.36 minutes per sample, this method is ideal for operations requiring fast turnaround times that won’t disrupt the production of their products.
This application note outlines a fast, robust and accurate solution for the quantification of ethanol and IPA in hand sanitizers for label claim purposes., An efficient and simple, “dilute and shoot” method is demonstrated for the analysis of IPA and ethanol in hand sanitizer products
Advances in Food Testing & Environmental Analysis eBook
This eBook includes application notes outlining a range of methods from Agilent from food and beverage testing to dioxin and volatile organic compounds analysis. Click on the titles below for full details.
Learn about methods to for detection 1,4-dioxane in consumer products including: cosmetic, personal care, and cleaning products, Learn about the 8697 headspace sampler as a means of introducing VOCs trapped in soils and sediments, Learn about the 8697 headspace sampler as a means of introducing VOCs trapped in soils and sediments
How to Choose the Right Atomic Spectroscopy Technique
An introduction to atomic spectroscopy (AAS, GFAAS, MP-AES, ICP-OES, ICP-MS and ICP-QQQ): how the techniques differ, how samples are prepared for analysis, and the setup needed in your lab.
Includes guidance on how to choose the right elemental analysis technique to suit your lab’s requirements.
The fundamentals of atomic spectroscopy, How commercially available techniques differ, Which technique is best suited for which analytical requirements?, What you’ll need in your lab to support an atomic spectroscopy technique
Automated Isolation and Reanalysis of Impurities
Isolation of impurities for further characterization is a routine task in the pharmaceutical industry and is often performed using preparative high performance liquid chromatography (HPLC). Usually, some steps of the workflow require manual interaction, making the whole process time-consuming and error-prone.
This application note demonstrates how automation can help to accelerate the workflow and eliminate error sources. The presented workflow includes method development on an analytical scale, upscaling to preparative conditions, fraction collection, and fraction reanalysis.
Scaling an analytical method to preparative conditions, Overloading the preparative column for higher yield, Selecting fractions for automated homogenization and reanalysis, The importance of reanalyzing fractions
High-Performance Biopharma Analysis
In this application note, learn more about Agilent's InfinityLab Bio LC Solutions
Which CQAs are most relevant, How to analyze CQAs and other biomolecules, Discover the advantages of a bio-compatible system over a stainless-steel system
Using Selectivity of Fused-Core Particles to Maximize Resolution for Improved LC and LC-MS Method Development
Today’s chromatographers face the same challenges that chromatographers faced 25years ago—to develop methods that maximize resolution between their analytes of interest. Selection of an appropriate pH for the analytes of interest is critical for ionizable compounds. Once the stationary phase, organic solvent, and pH are selected, vary temperature and gradient time. Then use of a commercially available method optimization software package is recommended. While C18 is a good all-purpose phase for initial method development, the other phases offer alternate selectivities. It is good practice to screen multiple phases to ensure the best possible separation.
Learn how to utilize unique stationary phase chemistries to maximize selectivity in HPLC/UHPLC and LC/MS, Learn about new stationary phase technology that will improve analyte resolution and lab productivity, Review examples of using different bonded phases to improve LC and LC-MS separations
Understanding the Benefits of ChemDraw® Embedded in an Electronic Lab Notebook
Of all enterprise cheminformatics applications, electronic lab notebooks (ELN) place the most stringent demands on embedded chemical editors. ELNs not only exercise the editor as a chemical query tool, but also require authoring complex reaction schemes, performing stoichiometry calculations, generating chemical properties, and even automating the authoring of synthetic preparation narratives from the chemical reaction drawing.
Learn all the benefits you will derive when ChemDraw, with its 35 year track record of continuous innovation in chemical communications, is enhanced by being embedded in the PerkinElmer Signals™Notebook.
Understanding how an embedded editor acts just like the standalone ChemDraw application, How to avoid the technical challenges typically found with embedded chemical editors, Enable Ctrl-C/Ctrl-V support from within any browser, How to rapidly and consistently document, share and re-use the preparation details of your chemical synthesis.
Top Ten Tips and Tricks that Many ChemDraw Users Don't Know About
ChemDraw has been the world’s preferred chemistry communication tool since its inception in 1985. Just about everyone in the scientific community has come across ChemDraw. Or, has used it in their labs at some point.
ChemDraw provides time-saving chemical intelligence, publication-worthy graphical templates, and scientific tools. We frequently hear, “I’ve been using ChemDraw for years. I already know how to use it”. But do you?
Download our white paper to learn the latest user-acclaimed tips that will dramatically increase your productivity by saving you valuable time.
Whether you’re an experienced chemist or an aspiring one, ChemDraw allows you to draw organic chemistry without having to master drawing.
Just a few of the important tips you will learn include:
- New Hotkeys and Shortcuts
- Old but gold Windows/Mac general shortcuts
- Reaction Auto-numbering
- Partnerships and Integrations
- ChemDraw JavaScript, and ChemDraw Add-ins
Boost productivity by using the latest ChemDraw key features, Save time when creating and publishing drawings, Draw organic chemistry without having to master drawing
Superior Selectivity in Proteomics
The success or failure of many mass spectrometry experiments depends on the ability to reliably detect low-abundance peptides of interest while screening out unwanted noise. High-field asymmetric waveform ion mobility spectrometry (FAIMS) can help users achieve superior selectivity by diverting targeted ions into the MS instrument for analysis, while deflecting away non-target ions that would otherwise generate background interference. This ebook introduces readers to the Thermo Scientific™ FAIMS Pro™ interface, and explores how various research groups in both academia and industry are making use of this technology in their proteomics work. For example, FAIMS can improve limits of detection in assays designed to detect signature of infection or cancer-related biomarkers, or enable superior quantitation in multiplexed MS experiments performed with isobaric labeling techniques. FAIMS Pro offers a simple and user-friendly means for introducing this powerful additional separation step into proteomics experimental workflows, and we hope that these case studies will inspire even more creative applications of this technique in the MS user community.
How FAIMS Pro interface can improve data independent acquisition for phosphopeptide analysis, How top down proteomics can utilize orthogonal separation on FAIMS Pro interface for protein analysis., How FAIMS Pro interface can increase the number of crosslinked peptide identifications for structural biology applications by enriching for specific precursor charge states.
Spurring automotive innovation with soy
Transportation is integral to the American way of life. However, the automotive industry is tied with the petrochemical industry, which has raised issues with environmental safety, climate change, and sustainability.
To address the issues of the environment, climate change, and sustainability in the automotive industry, researchers have been developing industrial and commercial products from soybean oil. Many of the most exciting uses of the soy relate to products that can make cars and the driving experience itself more sustainable and environmentally friendly.
Learn how soy-derived chemicals make hardier, more durable asphalt., Find out how soy-based chemicals can be found in commercial tires., Discover how car engines can run better with soy-based lubricants in motor oils.
Opportunities abound for soy bioplastics
Until recently, the fate of biobased plastics seemed intertwined with petroleum. Interest in them rose and fell with oil prices. Now, even with the precipitous drop in oil prices due to the COVID-19 pandemic, environmentally conscious consumers’ demand for sustainability, coupled with strict state and federal regulations and bans on non-biodegradable and non-compostable single-use plastics, have pushed agriculturally-derived materials to the forefront.
Plastics made from soy feedstocks hold many advantages for consumers. Soy is a renewable agricultural resource that sequesters atmospheric carbon. Bioplastics from soy, unlike traditional, petroleum plastics, can be synthesized to be industrially compostable or biodegradable. This whitepaper explores the many ways that soy can be used to create environmentally-friendly plastics.
How agriculturally-derived plastics meet the needs of today’s consumers, What compostable and biodegradable plastics made from plants are, and how they can be synthesized, What the advantages are of bioplastics made from soy feedstocks
Nitrosamine Impurities Analyses Application Guide
New opportunities for soy-based surfactants
Surfactants made from natural, renewable sources, such as like plant-based oils, have less environmental impact than ones made from nonrenewable sources. Scientists are seeking new applications for surfactants derived from natural sources — soy in particular — with potential applications in personal care products, laundry detergents, and environmental bioremediation.
As ballooning consumer interest in cleaning products sourced from renewable resources dovetails with public efforts to limit toxic environmental contamination, surfactants made from high oleic soybean oil seem poised to reshape the market.
How surfactants lower surface tension at the interface between polar and nonpolar materials. , Why surfactants from petrochemical derivatives have been widely adopted, but have problems., How chemists are now developing high oleic soybean oil-based surfactants for use in household detergent markets where more dangerous alternatives have been banned.
How can outsourcing buffer preparation help meet the world's urgent need for a COVID-19 vaccine?
As the SARS-CoV-2 crisis maintains its grip on the world, the pressure to develop and distribute effective treatments and vaccines continues to mount. To spare as many people as possible from this deadly disease, treatments and vaccines that are developed for human use will need to be produced and distributed in massive quantities. So far, there is no approved treatments or vaccines available worldwide. To meet the worldwide demand, drug companies will have to scale up their manufacturing capabilities dramatically. In this planning, buffers must be taken into account. These solutions are indispensable for drug development and manufacturing processes and outsourcing can be essential to increasing manufacturing capacity and speed.
This whitepaper from Thermo Fisher Scientific explores the decisions and economics behind outsourcing buffer preparation.
Why buffers are important in the production of biologics and how decisions surrounding buffers can affect the manufacturing process, How buffer outsourcing can improve manufacturing process efficiency and enable fast scale-up, How to understand and assess the cost-efficiency and economics of buffer outsourcing
Get in the mRNA vaccine race with affinity purification
A new vaccine technology based on mRNA is being tested in human clinical trials, accelerated by the COVID-19 global pandemic. mRNA-based therapeutics for a range of other conditions, from cystic fibrosis to cancer, are also entering early stage clinical trials. As mRNA production rapidly scales up, the critical need for a highly scalable mRNA purification technology has also emerged.
Thermo Fisher’s POROS™ Oligo (dT)25 affinity resin is tailor made for scalable mRNA purification. The mRNA sticks to the resin and impurities are washed away. This whitepaper examines the need for highly scalable mRNA production, and then explores the affinity resin’s advantages over other mRNA purification techniques.
What mRNA vaccines and therapeutics are, and their great promise and potential advantages over rival biomedical technologies. , Why the existing methods for mRNA purification are not amenable to large scale mRNA manufacture., How the Oligo (dt)25 affinity product works, and its advantages as a highly scalable mRNA purification product.
Environmental Analyses of Harmful Chemical and Organic Compounds Using Superficially Porous Particle Separations
With the worldwide concern about the ubiquitous presence of pollution and unhealthy levels of chemicals in the environment, the urgent need for monitoring and measuring these in multiple matrices is undeniable. For its part, the EPA has developed, validated and published several LC methods for PFAS and PAH analysis. PFAS analysis can be a challenge for chemists because there are PFAS compounds present in LC systems which can interfere with accurate quantitation, especially at low ppt levels. To combat this, a delay column is recommended to prevent PFAS contamination from coeluting with analyzed samples. Improvements in environmental separations are enabled by utilizing Fused-Core® columns.
About PFAS contamination from LC systems and how to prevent it, How to utilize mass spec for PAH analyses, Review examples of different environmental applications
Critical API Attributes and the Major Impact They Can Have on Drug Product Development
Small molecule drug substance development is often completed without consideration for the final drug product formulation. To some extent this is necessary, as drug substance must be generated before any product development activities can commence. However, both activities are intimately linked by the final purification and isolation step of the chemical synthesis and manufacturing process.
Read this whitepaper to discover why an alternative, integrated approach to formulation should be considered based on the impact of certain API properties on the final drug product.
Impact of API properties on formulation, Impact of particle size, The importance of an integrated drug development approach
Considerations and Best Practices for Mobile Phase Buffer Selection and pH Control for LC and LC-MS Method Development
When developing a new LC or LC-MS separation, careful consideration of mobile phase composition is essential for optimizing peak shape, improving separation selectivity, and ensuring method robustness. For samples containing ionizable compounds, it is important to select and appropriate mobile phase pH to control the analyte ionization state, to achieve reliable retention times.This white paper discusses the important aspects to consider when selecting mobile phase buffers to ensure the development of robust and reproducible LC separations.
Learn about mobile phase buffer selection to improve their chromatography, Learn how controlling mobile phase pHwith buffers will reduce retention shifts, How accurately documenting procedures ensures method reliability and reproducibility
Breaking through bottlenecks in organic synthesis with a streamlined purification workflow
Successfully completing an organic synthesis involves three typically lengthy, but crucial steps: reaction monitoring, compound identification, and purification. These steps can create bottlenecks in the synthesis, unless a purpose-built, streamlined, and reliable workflow is on hand.
This whitepaper delves into some of the challenges faced by synthetic organic chemists as they navigate compound identification and purification struggles. It also describes how using a workflow that couples thin layer chromatography (TLC) and mass spectrometry (MS) to flash purification can help increase the efficiency of the entire process.
Understand how a workflow that combines thin-layer chromatography, mass spectrometry, and flash purification can increase the speed and efficiency of an entire organic synthesis process., Learn about prep-free techniques that have become the new standard: scraping TLC spots, developing flash methods and performing long liquid chromatography/MS runs are not necessary with modern instrumentation that is specifically developed to take the pre, Become informed about a cost-effective, user-friendly benchtop workflow solution for organic compound identification and purification that can save time and money for any lab.
Beyond a Drawing Tool: The Evolution of a Comprehensive, Chemically-Intelligent Solution for Chemistry Communication
As the world moves towards increased automation, electronic record-keeping, and cloud connectivity, there is also significant innovation in communication tools. For chemists, these innovations are bringing about revolutionary changes in how they share their research.
Learn how innovative software can empower today’s chemists to search, reuse, and report their ChemDraw data efficiently and seamlessly. This whitepaper delves into the current communication struggles in chemistry research and how they can be easily overcome with purpose-built, innovative software.
ChemDraw and ChemOffice+ Cloud simplifies, facilitates, and accelerates chemistry communication and transforms chemical drawings into shareable chemical knowledge., How to overcome the lack of efficiency in conducting admin tasks, and how to navigate siloed reporting applications and databases., How to easily search and find chemical data buried deep in your files. ChemOffice+ lets you extract and re-use existing chemical content from old ChemDraw files stored inside MS Word, PowerPoint, and SD files without having to open them., How to create and manage lists of compounds and effortlessly produce reports. ChemOffice+ Cloud allows you to quickly create collections – lists of molecules or reactions with a reporting purpose – that you can annotate, edit, and export as PowerPoint and, How to automatically generate consistently formatted reports and make your chemistry more visually compelling and easier to follow.
Analysis of Biogenic Amines in Wine
Biogenic amines are naturally occurring organic bases formed by fermentation processes or bacterial decarboxylation of amino acids. As they can be an indicator of poor hygienic conditions and spoilage of food products, there is a need for analytical methods ensuring compliance with concentration limits. This application note describes a reliable method for the direct analysis of biogenic amines using LC/MS. Ion pair chromatography is used to gain separation of biogenic amines on a reversed phase column avoiding the need of a time-consuming and unspecific derivatization procedure. Exemplary, a Tempranillo red wine is evaluated regarding toxicological thresholds of biogenic amines stated by the European Food Safety Authority.
Elevated levels of biogenic amines are an indicator of poor food quality, Biogenic amines can be reliably analyzed via LC/MS, Direct analysis of underivatized biogenic amines via ion pair chromatography enables high throughput and reproducibility
Achieving Successful Method Translations in Liquid Chromatography
The aim of this whitepaper is to bring together the theory, principles and key equations that are required for method translation and demonstrate their use for the translation of isocratic and gradient LC methods. Additionally, common pitfalls and key considerations of LC system characteristics are discussed, to help maximize the chances of successful method translation.
Learn the process required to translate LC methods that accurately replicate the selectivity, resolution and performance of the original method, Review the most common issues encountered in translating methods and their potential solutions, Review examples of the LC method translation process
A Novel Approach to Glycan Method Development for Biotherapeutics using Superficialy Porous Particle Technology
Given the importance of glycosylation to overall performance of a glycoprotein, there is a need to completely characterize and then monitor these glycans for both research and manufacturing purposes. Traditional methods of analysis rely on cleavage of the glycans from the protein backbone, label with a UV- or fluorescence based tag, and separation and identification of the glycans by HPLC/MS. Following identification, the subsequent characterization and routine monitoring can be done using HPLC/UV or HPLC/fluorescence.
However, since the glycans attached to any protein come from a known set of glycans, the goal of this work was to develop and optimize a universal method to separate and completely characterize all potential glycans from any protein. This may entail a long, comprehensive analysis, which is acceptable since the characterization is done only a few times during product development. A second goal was to develop a rapid, routine method to be used for monitoring and control during process development or final manufacturing.
Learn how to develop a glycan LC method utilizing method optimization software, How to utilize a longer gradient method and a rapid gradient method to support in-process testing, Review examples of the glycan method development process
Working With UHPLC: Accelerating Method Development, Speeding Up Routine Analyses and Achieving Ultra High Resolution
UHPLC has now been widely adopted within many industry sectors for both routine analysis and method development, due to reduced analysis times. The application of novel stationary phase chemistries that maximize selectivity in UHPLC have only enhanced the technique’s appeal with method developers.
This white paper explores these key advantages of UHPLC and demonstrates how the latest column technology and novel chemistries can be applied to accelerate both method development and routine analysis.
Learn how to utilize unique stationary phase chemistries to maximize selectivity in UHPLC., Learn about an LC Translator and method transfer calculator to help with calculations for method translation and transfer., Review examples of translating and transferring methods to UHPLC using the LC translation and transfer tool.
Understanding and Overcoming Separation Challenges in the Biological Drug Development Process
Biological drug development requires testing at many stages during and after the process. Separations, especially HPLC, are very important in this testing. Process, Characterization, and Final Release/QC all have specific requirements. Use of Fused-Core® columns can be beneficial in all developmental stages to maximize analytical efficiency.
An overview of the Drug Development Stages, Proposed strategies for developing versatile platform methods that can be used or easily modified for all stages and needs in drug development, Strategies implementing methods for both characterization of intact mAbs
Top Ten ChemDraw® Tips and Tricks That Many Users Don't Know About
“I’ve had ChemDraw for so many years, I already know the best ways to use it.”
From a customer
This paper is about the ten tips and tricks – five old favorites and five new ones – that ChemDraw fans might have missed. Mainly because there are so many tips and tricks available in ChemDraw that it is difficult to know everything. Plus, there’s always a powerful, new release coming out so new functionality can go unnoticed.
The best shortcuts that save chemists hours every week, How to improve personal productivity, How to create the most professional looking, accurate materials with ease
The LC Side of "Do More with Less"
Routine laboratories are the analytical facilities that continually strive to keep our water, food, medicine, and consumer goods safe, effective, and authentic. Over the years, the pressures on these labs has steadily increased because of spiraling operational and staffing costs, ever-more complex analyses, and the need to stay abreast of changing technology.
This eBook shares some of the unique, sophisticated, and sometimes space-travel worthy, liquid chromatography solutions that Agilent has developed to assist analytical scientists in their work. The Agilent InfinityLab LC Solutions described here include those that increase sample throughput, boost uptime, and maximize space utilization. Every single tool was designed to be robust, intuitive, and a joy to use, and ultimately, to boost lab productivity, profits, and employee satisfaction.
Tips for increasing lab employee satisfaction and retention, Ways to maximize the flexibility of your LCs, How LCs can contribute to your company’s operational and sustainability goals
Take Your UHPLC and HPLC Methods to the Next Level of Speed and Resolution with Fused-Core® Columns
Fused-Core® columns can deliver both fast and high resolution separations that allow chromatographers to choose the best combination of particle size and column geometry appropriate for their methods and their instrumentation. The application of 2 μm columns using appropriate instrumentation provides more separation power than previously available using 2.7 μm SPP columns. For ultra-fast, high-throughput separations of samples in 96–384 well plates, ultra-high resolution separations of impurities in new and generic pharmaceuticals, complex environmental sample separations and challenging LC-MS separations, Fused-Core columns can deliver superior results, both accurately and reproducibly, in a timely manner.
Learn why Fused-Core particles will increase the efficiency of your chromatography compared to fully porous particles., Learn the benefits of Fused-Core technology to implement into their daily chromatography workflows., Review examples of translating and transferring methods to UHPLC using Fused-Core particles.
Overcoming Challenges of Conventional Immunoassays in Biopharmaceutical Manufacturing with a qPCR-Based Approach
The demand for cleaner, higher-purity biopharmaceuticals is pushing the frontiers of residual protein detection methods. New applications of antibody-based methods and qPCR rise to meet the challenge. ProteinSEQ, a powerful assay method, delivers dependable results and minimal background noise within a vast detection range.
New methods of residual protein detection, Host Cell Proteins (HCPs) and their relevance to biopharmaceutical processing, Proximity ligation assay using oligonucleotide probes
Molecular Spectroscopy of Glues for Quality Control and Development
Adhesives are indispensable in the automotive, aeronautic, and medical industries, among others. Modern adhesives are complex, and their quality requires an assessment of initial components as well as the final product. Molecular spectroscopy approaches, including FTIR and Raman, can be used to identify the components of a sample within seconds without any sample preparation, reagents, or consumables, offering a fast and effective route to glue analysis. Microspectroscopy can detect defects and inclusions on adhesive surface, while confocal Raman microscoscopy provides a unique capability: to analyze materials in depth without the need for a cross-section.
Spectroscopic analysis of glues, Incoming goods inspection via FTIR spectroscopy, Measurement of curing time for an adhesive, Reverse engineering of an adhesive, Failure Analysis using FTIR microscopy
Lubricating Performance: Using Soybean Oil for Performance and Sustainability
Soybean oil provides a cost-effective base material for a wide range of lubrication fluids while having an environmentally favorable footprint. There are good performance reasons for using soybean oil in lubricant formulations. It has well-established uses and supply chain infrastructure. New developments in chemical modifications and soybean agriculture are leading to more effective soy-based lubricant.
Good lubrication Performance • Enhanced lubricity • High viscosity index • Low evaporation loss • Low flammability, A sustainable and renewable option for a broad range of lubrication applications requiring low toxicity and readily biodegradability., Established uses as lubrication fluids in hydraulic cylinders, metalworking machines and moving surfaces where the lubricant is lost directly into the environment., Improved thermal stability with the recent development of high oleic soybeans., Renewable by nature, soybean production is responsible for significant greenhouse gas reduction
Insights into Protein Stability in Pharmaceutical Formulations
Fourier Transform Infrared (FTIR) spectroscopy is a very sensitive method that has been successfully employed in the field of protein biochemistry. This method allows for the accurate characterization of the secondary structure of proteins in aqueous solutions as well as the identification and quantification of conformational changes. FTIR spectroscopy has proven to be very useful, especially in the field of pharmaceutical formulation of therapeutic proteins, such as Antibodies. Further, the routine determination of protein stability under varying conditions is a challenging task that is important for assessing long-term viability.
Conditions that allow protein to remain stable, How to assess protein structures in aqueous solutions, Identification and quantification of conformational changes in protein structures, Routine determination of protein stability under varying conditions
Improving Liquid Chromatographic Separations in Clinical Analysis by Utilizing Recent Developments in Column Technology
Liquid chromatography (LC) is a powerful technique for the separation, identification, and quantification of target analytes in complex media such as biomatrices. LC offers target assay flexibility, multiple detection modes, and can be highly automated — all of these are ideal features to be applied to the analysis of high sample numbers or for research purposes in the modern clinical laboratory.
With the introduction of ever-more-powerful and easier-to-use mass spectrometry (MS) detectors at an affordable price point, LC-MS has become increasingly influential as a routine, investigative tool for clinical testing, therapeutic/dose monitoring, and the screening of disease states including quantitative and qualitative biomarker profiling.
Learn how to utilize unique stationary phase chemistries to maximize selectivity in HPLC/UHPLC and LC/MS, Learn about new stationary phase technology that will improve clinical analyte resolution and lab productivity, Review examples of using different bonded phases to improve clinical lab separations
Experiential Education: Mass Spectrometry Enters the Undergrad Lab
Inexpensive compact mass spectrometers are expected to continue their charge into university teaching laboratories, where their speed, usability and robustness are enabling – in many cases, for the first time – undergraduate students to have hands-on experience with an instrument that they are increasingly likely to encounter if they progress through a scientific career.
The use of mass spectrometry is continuing to grow., To support the field’s growth, it important to train the next generation of scientists in practical mass spectrometry., Giving undergraduates hands-on training in the teaching lab is becoming easier and more affordable thanks to a new generation of small, robust mass spectrometers., Students are the beneficiaries of an experiential mass spectrometry education.
Biobased Resins in Coatings, Presented by Lee Walko at the Eastern Coatings Show 2019
The following is an excerpt from a presentation given by Lee Walko, USB consultant and biobased business development director with Omni Tech International, Ltd., at the Eastern Coatings Show 2019. The presentation includes the basics of soy chemistry in coatings, including the structure of a soy oil triglyceride, some reasons why soy is used in coatings, the basic building blocks of soy in coatings and future possibilities.
Soybean oil is naturally hydrophobic, allowing for increased water and chemical resistance when used in coating formulations., Soybean oil chemistry also contributes to film hardness, durability and impact resistance, which allows formulators to produce high-performing paints and coatings., Due to both internal initiatives and government legislation, companies are hyper-focused on reducing the amounts of volatile organic compounds (VOCs) in their formulations, which is also a huge driver for using soybean oil in paints and coatings.
Analyses of Large Proteins, Antibodies, and Modified Proteins Using A New Series of Advanced Large Pore HPLC Materials
As pharmaceutical companies have shifted their development focus to large-molecule biotherapeutics, the ability to separate intact monoclonal antibodies and antibody-drug conjugates for characterization purposes has become extremely important. To enable this characterization work, new LC particle technology has been required. The large 1000 Å pore size of the superficially porous particles used for RPLC described herein enables full access to the bonded phase surface for larger biomolecules. This improved access to the bonded surface produces narrower peak widths and enhanced resolution of minor mAb variants, and can lead to increased retention under most analysis conditions. Together, with new mass spectrometric instrumentation and software, wide-pore superficially porous particle LC columns will greatly aid in the advancement of large-molecule biopharmaceutical characterization and development. The recent expansion of the very large pore superficially porous particle family to include three bonded phases (C4, C18, Diphenyl) permits very high resolution separations of lower abundance protein variants, permitting structure analysis and quantification of these variants.
Develop a strategy for separating large, complex proteins (> 50,000 MW), How to utilize larger pore sizes to improve the efficiency and robustness of your large complex protein separations, Review several examples in which larger pores were used to improve protein separations
Affinity Tags Head Toward the Vaccination Clinic
Researchers typically avoid using affinity tags in the purification of therapeutic proteins. Recently, one very short affinity tag—just four amino acids long—proved its worth for purifying a malaria vaccine candidate for clinical trials. This has opened the door to a range of novel protein-based malaria vaccine candidates, which are now either in or progressing toward clinical trials.
Example of C-tag being used to accelerate vaccine development, C-tag system is a viable technology for GMP-compliant manufacture of therapeutic proteins, Understanding how the C-tag affinity tag system functions
Accelerating UHPLC/HPLC Method Development and Maximizing Chromatographic Selectivity with Novel Stationary Phase Chemistries
In all types of modern laboratories, it is increasingly important to be able to carry out accurate and reproducible HPLC analyses with excellent turnaround time and throughput. For those laboratories that must develop, validate, and use methods over a significant period of time, or those that must transfer methods to other laboratories around the world, it is a practical business advantage to be able to develop robust and rugged methods more quickly. For both of these situations, it can be beneficial to have a diverse group of column chemistries from which one can choose and use to explore chromatographic selectivity.
Utilize chromatographic selectivity to maximize analyte resolution, Explore the chromatographic selectivity and properties of uniquely designed stationary phases to understand different modes of interaction between the analyte and the stationary phase, Explore method development approaches from simple to complex and how different variables influence selectivity
Toxtyper for Automated and Semi-quantitative Screening of Drugs Consumed in Drug Consumption Rooms
In this study the Toxtyper is used for drug screening in drug consumption rooms which are seen as an important element to minimize drug-related health problems (e.g. infection risk) and promote contact of drug users with employees of drug help programs.
About the quantitative comparison of typical drugs such heroin and cocaine between the European Drug Report and this study (drug consumption room), How the Toxtyper is used for fast and automated qualitative drug screening, How semi-quantitative analysis can be achieved by the Toxtyper
The Quest for High Effective Resolution: Therapeutic Protein Characterization via Separations-coupled Native MS
Intact mass analysis is a key characterization step for any therapeutic protein of interest as a prospective biologic drug. This whitepaper describes the latest approaches for optimizing intact mass analysis using separations-coupled MS.
The whitepaper describes the latest advances in methods, hardware, and software for intact mass analysis. It desribes how these advances could be combined to further push the boundaries for intact mass analysis for complex heterogenous biologic samples.
The priniciples of intact mass analysis for therapeutic protein characterization, The latest advances in separations and mass spectrometry hardware, New methods to optimize hardware performance
Opening Doors to a Whole New View of Biology with Mass Spectrometry
Liquid chromatography and mass spectrometery (LC-MS) have transformed the field of proteomics, enabling researchers to rapidly survey the contents of complex biological samples. However, until relatively recently it has proven challenging and labor-intensive to perform accurate comparisons across multiple samples.
Tandem mass tags (TMT) have proven to be a transformative tool in this regard. Using TMT technology, researchers can add isobaric labels to multiple samples, which can then be analyzed in a single tandem MS experiment. These capabilities are making it possible to sensitively detect rare peptide species, to identify differences between healthy and diseased tissue, and conduct sophisticated surveys of the cellular proteome. This ebook provides an overview of the TMT technology, and offers five case studies that illustrate some of the cutting-edge applications for which these reagents are being used.
Learn how TMT technology enables highly multiplexed sample analysis with LC-MS, Learn how synchronous precursor selection (SPS)-based MS3 unlocks the full potential of TMT technology, Explore powerful applications of this technology for both basic and clinical research
Multi-omics in Cancer Research
The genome has given clinical researchers a powerful tool for understanding the biological foundations of many diseases, but it only tells part of the story. This ebook shows how different laboratories are employing mass spectrometry and other cutting-edge tools to collect richer datasets based on a combination of multiple ‘omes,’ including the proteome, metabolome and transcriptome.
Through the integrated analysis of these molecular profiles, researchers can glean insights that would be impossible to obtain with any one dataset alone—for example, the mutations in the genome can be a poor predictor of actual gene expression or protein production. The case reports presented in this collection show how these multi-omic analyses can potentially lead to earlier and more accurate research predictions, and ultimately, to possible individualized treatment regimens.
How longitudinal analysis of multi-omic data offers new insights into human health and disease, How a combination of proteomics and genomics can enable more sophisticated tumor profiling, How broad kinome analysis can be paired with DNA and RNA analysis to study and overcome cancer drug resistance
Microplastics: from Beach to Bench—Complete Characterization and Chemical Identification of Microplastics Using Mobile FTIR and FTIR Imaging Technologies
As plastics continue to enter the environment, understanding their global impact is vital to addressing microplastic pollution. Since its emergence as an environmental and potential human health threat, researchers have strived to develop tools for accurately measuring microplastics in environmental and food matrices using FTIR-based techniques and automated data handling.
This study examines the current status of methods of microplastic quantification and identification and presents the analysis of microplastics smaller than 10 microns in a sample of soil from a marina using FTIR imaging, combined with a free software program, MPhunter.
Methods of microplastic quantification, Analysis of microplastics smaller than 10 microns, FTIR-based techniques and auto¬mated data handling
Microplastics: from Beach to Bench—Complete Characterization and Chemical Identification of Microplastics Using Mobile FTIR and FTIR Imaging Technologies
As plastics continue to enter the environment, understanding their global impact is vital to addressing microplastic pollution. Since its emergence as an environmental and potential human health threat, researchers have strived to develop tools for accurately measuring microplastics in environmental and food matrices using FTIR-based techniques and automated data handling.
This study examines the current status of methods of microplastic quantification and identification and presents the analysis of microplastics smaller than 10 microns in a sample of soil from a marina using FTIR imaging, combined with a free software program, MPhunter.
Methods of microplastic quantification, Analysis of microplastics smaller than 10 microns, FTIR-based techniques and auto¬mated data handling
Maximizing Throughput, Robustness and Analytical Depth for Shotgun Proteomics
Increased peak capacity provided by the TIMS technology coupled to a QTOF mass spectrometer and the PASEF acquisition mode together with novel chromatographic separation technology provides beneficial separation to analyze 200 samples per day. The high speed of the new mass spectrometer enables measurement at sufficient analytical depth and robustness and is ideally-suited for the measurement of large sample cohorts.
How TIMS and PASEF technology on a QTOF instrument can be used for high-throughput shotgun proteomics
EPR – The 'Workhorse Technique' That is Still Enabling Scientists to Break New Ground After 70+ Years
A surprisingly large number of materials have unpaired electrons. These include free radicals, many transition metal ions, and defects in materials. Free radicals are often short-lived, but play crucial roles in many significant processes such as photosynthesis, oxidation, catalysis, and polymerization reactions.
Electron paramagnetic resonance (EPR) spectroscopy is the only method for the direct detection of species that have unpaired electrons, and its applications span one of the widest ranges of any analytical technique.
How EPR works, New developments in EPR technology, How it can be used for in different applications, such as drug development and photovoltaic material research
Efficient Removal of Aggregates from Monoclonal Antibodies
Monoclonal antibody (mAb) therapeutics have been widely used to treat various diseases, including cancer. Oftentimes, dimers and other high molecular weight aggregates are present in the mAb therapeutics, leading to reduced biological activity. Traditionally-used methods for aggregate removal rely heavily on anion exchange chromatography (AEX) in flow-through mode followed by a generic bind/elute polishing step. While there are several advantages associated with these methods, they are often time-consuming and expensive. This whitepaper reports the use of hydrophobic interaction chromatography (HIC) in lieu of the generic bind/elute polishing step, for the removal of aggregates from mAb therapeutics. HIC is a more simple and cost-effective method, leading to higher selectivity towards mAb aggregate removal.
The principles of hydrophobic interaction chromatography (HIC) for monoclonal antibody (mAb) therapeutic aggregate removal, A comparison of HIC to traditionally-used mixed-mode bind/elute chromatography-based methods for aggregate removal, Optimization of HIC for optimal aggregate removal at various pH levels and salt concentrations
Analysis of Microplastics using FTIR Imaging: Identifying and quantifying microplastics in wastewater, sediment and fauna
This study describes a new method of quantifying different types of microplastics in environmental samples using FTIR imaging. The method utilized was able to successfully recover, identify, and quantify microplastics in organic-rich samples such as sediment, water, and fish.
The method utilized FTIR imaging, combined with the MPhunter software and proved to be a rapid and accurate way to automatically identify and quantify microplastics and other materials. Combined with H2O2 oxidation, FTIR imaging is a strong candidate to be a standard method in microplastic analysis, allowing further study and understanding of microplastics in the environment
Identifying and quantifying microplastics with FTIR imaging, Microplastic Analysis in the environment, FTIR-based techniques
A LC-MS Approach to Screen Drugs in Drug Consumption Rooms
In this study the Toxtyper is used for drug screening in drug consumption rooms which are seen as an important element to minimize drug-related health problems (e.g. infection risk) and promote contact of drug users with employees of drug help programs.
About the quantitative comparison of typical drugs such heroin and cocaine between the European Drug Report and this study (drug consumption room), How the Toxtyper is used for fast and automated qualitative drug screening, How semi-quantitative analysis can be achieved by the Toxtyper
Using Reversed-Phase Liquid Chromatography for Large Proteins and Antibodies Analysis
For many years pharmaceutical companies have taken a deliberate approach for creating new small molecule drugs for disease treatment. These new chemical entities and their analogs were often synthesized in large numbers and then tested for efficacy for treatment of various diseases. With the small molecule drug hit rate dropping and with recombinant protein synthesis becoming available and growing explosively, it became possible to manufacture biopharmaceuticals which could be used to treat diseases that could not have been considered previously. Many pharmaceutical companies have focused more and more of their efforts in this area, and new biopharma companies have grown around this important area. A number of large, small molecule-focused pharmaceutical companies have also purchased or merged with startup biopharmaceutical companies to acquire their pipelines and their expertise.
Better understand the complexity involved in analyzing high molecular weight protein biopharmaceuticals., Learn how the latest Innovations in reversed-phase liquid chromatography have automated and simplified analysis of complex mixtures of proteins., See a case study on how to separate and quantitate Trastuzumab, Silumab, and other monoclonal antibodies.
Toxtyper: Detection of Opioids and Prescription Drugs at Miami Dade
Ongoing evolution of new designer drugs, also known as new psychoactive substances (NPS), requires continuous updating of screening methods when determining the suspected role of NPS in deaths. The open library concept of the Toxtyper system allows for rapid updates of methods linked to the appearance of new drugs. The following application note describes the development and validation of a sensitive screening method for the identification of the common prescription analgesics (e.g. oxycodone, methadone and buprenorphine) together with illicit substances such as fentanyl, beta-Hydroxythiofentanyl and other fentanyl analogs with detection limits in sub-ppb to low ppb range.
Learn how to develop a sensitive screening method for the identification of common prescription analgesics and illicit substances such as fentanyl and other fentanyl derivatives., Learn how to modify LC and MS conditions to optimize your protocol., See examples of how to screen for 30 prescription drugs simultaneously., Have a better understanding how whole blood samples can affect the limit of detection.
Nano-LC: Big Data From Tiny Volumes
The dominant technology of modern proteomics is certainly liquid chromatography-mass spectrometry (LC-MS). However, it is safe to say that the primary discussion point in terms of technology in proteomics has been the mass spectrometry part of this partnership. A great deal of emphasis is placed on the mass spectrometer and the data generated by it.
However, there has been less focus and emphasis placed on the separations of peptides and proteins prior to analysis by mass spectrometry in terms of the nano-LC chromatography systems and columns contributing to proteomics performance. One half of the LC-MS combination has been neglected.
Therefore it seemed to the authors that it was time this imbalance was redressed. The following handbook has been produced in an attempt to educate and inform on the relevance and significance to proteomics of liquid chromatography, in particular reversed-phase nano-LC directly coupled to MS.
Learn how reversed-phase nano-LC directly coupled to a mass spectrometer is revolutionizing the field of proteomics., Understand how decreased column diameter and gradient separation in nano-LC MS can increase sensitivity and increase signal strength., Learn how nano-LC MS can be used for large targeted screening and validation studies.
Mass Spectrometric Analysis of Intact Complex Biotherapeutics
The benefit of therapeutic antibodies is their ability to be inherently more selective than traditional small-molecule pharmaceuticals through specific binding activities, lower toxicity, and higher efficacy. And the proof of their benefits is in the numbers: The U.S. Food & Drug Administration approved 68 such therapeutics by the beginning of 2017,and more than 50 are being evaluated in late-stage clinical studies for a range of indications.
Because mAbs are produced from cell lines and fermentation processes, they are fundamentally less pure than traditional chemically synthesized products and are subject to possible degradation and chemical modifications throughout their manufacturing and storage. This lack of purity and the microheterogeneity inherent in the nature of the molecule (due to, for example, glycosylation) require significant and robust characterization not only during discovery and research but also throughout the drug development process, quality control, and lot release to ensure safety, efficacy, and consistency.
This whitepaper explores how LC/MS analysis of intact therapeutic antibodies can be performed with high accuracy and sensitivity down to subnanogram levels for molecular weight confirmation and assessment of isoform pattern. For the analysis of more complex molecules, such as antibody-drug conjugates, native mass spectrometry is beneficial to characterize the sample and obtain the accurate drug-to-antibody ration.
Create workflows for intact protein analysis, Analyze protein masses under denaturing and native conditions, Develop workflows for antibody subunits
How qNMR Brings Speed and Accuracy to Drug Development
The total cost of bringing a drug to market is now estimated at about $2.5 billion, and the pressure to advance new drugs faster is greater than ever. Part of the challenge is the rising expense of late stage drug testing, which now typically costs several hundred million dollars. But developers can speed their drugs to market more easily if they learn more about a candidate drug’s chemical characteristics as early in the development as possible. The goal is to invest as little as possible before the drug candidate has proven it’s potential.
Understand why qNMR can be a single point replacement for multiple alternative analytical steps., Learn how qNMR works, the latest technological advances in the field, and why it is so precise., Learn how the technology is used to determine potency., Understand how new software has made the technique easier to use by a wider range of professionals., See how qNMR can detect even small structural differences between compounds.
An Intelligent Solution for Hydrophillic Interaction Liquid Chromatography Method Development
In this white paper, it will be demonstrated that the use of three HILIC phases, which provide very different and complementary selectivity to one another, is both practical and effective for HILIC method development. These selectivity differences can be exploited, together with mobile phase pH, to thoroughly explore selectivity and to enable selection of an appropriate stationary phase/mobile phase combination during HILIC method development. A systematic, step-by-step approach to method development is recommended to make it easier for chromatographers to develop new HILIC methods in a productive manner.
When to Consider HILIC for Your Separation, How to Use Complimentary Selectivity and Mobile Phase pH to Improve Method Development, A Step-By Step Approach to HILIC Method Development
A complete reaction-monitoring solution: Compact mass spectrometry
Compact mass spectrometers (CMS) have revolutionized reaction monitoring, turning a once laborious and time-consuming task into a rapid and convenient process with instruments right at the chemist's bench or fume hood. These instrument can provide results in as few as 30 seconds, are cost-effective, and offer a growing number of sample techniques. This report reviews the advantages and applications of CMS systems as well as some case studies in their use.
What are the typical uses of mass spectrometers?, What are the specific advantages of CMS systems?, What techniques are now featured with such systems, and what are their applications?, How are different labs, with different focuses, incorporating CMS systems to improve their results and efficiency?
High Throughput Quantitative Proteomics Using Isobaric Tags
Proteomics techniques are rapidly evolving to become a highly sensitive, quantitative, and high-throughput approach to analyzing global protein dynamics within a cell, tissue or an organism.
The ability to perform accurate protein quantification at low levels lets scientists unravel the complexity of protein interactions and track abundance changes in a variety of targets. When combined with multiplexing capabilities that allow scientists to measure increasing numbers of samples across varying conditions in a single experiment, quantitative proteomics provides a better understanding of the molecular mechanisms underlying biological processes and disease states.
This whitepaper discusses critical advances in analytical technology driving this revolution in proteomic analysis, allowing biologists to explore the proteome at greater depth, measure changes in protein localization and quantify minute changes in low abundance proteins. Furthermore, four leading researchers discuss the use of tandem mass tag (TMT) multiplexing enabled by Synchronous Precursor Selection (SPS) MS3, and how it has facilitated groundbreaking discoveries in each area of their research.
How quantitative proteomics can showcase the dynamic and interactive nature of proteins, How to better understand underlying mechanisms of biological processes and diseased states, How a transformative MS technology enables significant gains in biological system characterization, How increased sensitivity and accuracy enables increased depth of analysis across larger numbers of samples
Analysis of Extractables & Leachables Overview, Technologies, Best Practices
Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&Ls may be inherently toxic or may contaminate or interact with drug products, posing a potential danger to patients. Even as regulatory guidance related to the application, performance, and reporting of E&L studies increases and examples and data accumulate, E&L analysis is still an evolving area of investigation. This whitepaper provides an overview of the current best practices in the analysis of E&Ls, including the basic principles of E&L analysis, how to design an E&L study, and a detailed look at workflows, focusing on analytical techniques and instrumentation, sample selection, and extraction conditions. The discussion also highlights the advantages and limitations of available and emerging separation, detection, and identification technologies, software tools, and quantitative methods development.
Potentially toxic chemicals that can leach from medical devices and pharmaceutical packaging materials pose a great risk., Sensitive and accurate analytical studies are essential to detect, identify, and quantify extractable and leachable compounds., A well-designed E&L study has four parts: gather background information; develop a study protocol; perform risk assessment; detect, identify, and quantify leachables., LC/MS and GC/MS are the workhorse techniques for E&L analysis. New analytical technologies include ELSD, SFC, 2D-LC, and ion mobility MS., Mass spectroscopy is the main analytical method used to identify extractables. Techniques for quantitation include GC-MS, UHPLC-UV, UHPLC-CAD, and QTOF-GCMS.
A Fully Automated LC-MS Workflow for Identifying Targets in Chemical Reactions
End-to-end automation of an integrated liquid chromatography-mass spectrometry (LC-MS) workflow for target screening applications is readily achievable and yields substantial advantages. An automated, robust platform that combines high quality target mass interpretation with fast analysis times can boost the efficiency and productivity of drug discovery laboratories. Thermo Fisher Scientific has designed and implemented an automated LC-MS workflow optimized for accurate target mass interpretation. Under the control of the Thermo Scientific™ Dionex™ Chromeleon™ Chromatography Data System (CDS) software, this customized, fully automated workflow is in operation at Bayer Pharma AG, with a reported success of finding the target mass in about 90% of more than 9,000 reaction controls studied to date.
Herein we describe a robust and efficient LC-MS workflow for high-throughput target mass analysis. It combines ultra-high performance liquid chromatography (UHPLC) and high resolution MS capable of accurate mass analysis and rapid compound identification and quantification. State-of-the-art Chromeleon CDS software synchronizes and controls the system components, ensuring a seamless workflow from the set-up and initiation of a screening run through data analysis and results reporting.
End-to-end automation of the LC-MS workflow enables rapid, high quality target mass analysis to boost productivity., Chromeleon CDS software synchronizes and controls all components of the UHPLC and high resolution MS workflow., Example of an automated workflow developed for a real-world target screening application at Bayer Pharma., In-depth account of Bayer’s early experiences and results of screening.
