2-Part Webinar Series: Current Trends, Analytical Workflows and Case Studies in Extractables and Leachables Analysis

October 25 , 2016

Part 1, First Session: 9:00am EDT, 6:00am PDT, 14:00 BST, 15:00 CEST

Part 1, Second Session: 9:00am EDT, 6:00am PDT, 14:00 BST, 15:00 CEST

November 17, 2016

Part 2, First Session: 9:00am EDT, 6:00am PDT, 14:00 BST, 15:00 CEST

Part 2, Second Session: 9:00am EDT, 6:00am PDT, 14:00 BST, 15:00 CEST

Overview

Highly publicized incidents and stricter regulatory controls have put a sharper focus on the analysis of extractable and leachable compounds (E&L) that may be found in pharmaceutical products, medical devices or that may be introduced during manufacturing. The advent of single use bioprocess systems in bio-therapeutics manufacturing has introduced a new potential source for E&L's as these systems are often comprised of polymers.

Come join us for a two-part webinar series, where we will explore various aspects in E&L analysis including current trends, changes to the regulatory landscape, and provide suggestions for study design, sample preparation and analytical workup of extracts.

Part 1

Extractables and Leachables, Part 1: Overview, Current trends and a Streamlined Workflow for Qualitative LC/MS and GC/MS Analysis

In the first of this two-part webinar series, we will discuss current trends in E&L analysis including changes to the regulatory landscape and present an overview of analytical technologies available for E&L analysis. We will review LC/MS and GC/MS software workflows designed specifically for E&L analyses which allow for the fast identification of extractables and potential leachables from samples. We will introduce a new high resolution LC/MS database comprising over 1000 common E&L compounds with toxicology literature references and MS/MS spectra in order to aid in the rapid identification of knowns and perform early risk assessment using the references in the database. We will also describe differential analysis for mining both LC/MS and GC/MS data which provides a convenient way of visualizing the large volumes of data arising from these experiments to facilitate presentation of results.

Speakers

Brought to you by:

Part 2

Extractables and Leachables, Part 2: Study Design, Sample Preparation, Analytical Workflows, and Case Studies

In the second of this two-part webinar series, we will present case studies in the analysis of E&Ls with a highlight on a model single use bioprocess system that may be used in the manufacture of large molecule drug products. The bioprocessing system case study involved following a science-based risk assessment approach to E&L study design through consulting guidance documents such as USP 661, 1663, 1664, ISO 10993, BPSA and BPOG as well as simulating actual use conditions by using a flow through extraction methodology together with other extraction approaches. A variety of analytical technologies and workflows were used for initial screening of the extracts for a holistic understanding of the samples followed by a more specific analysis by ICP/MS, LC/MS and GC/MS for detecting, identifying and quantifying elemental, volatile, semi-volatile and non-volatile compounds in the E&L extracts. Results from this study will be presented.

Speakers

Brought to you by:

Moderator