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Higher Order Structure (HOS) biocompatibility by Microfluidic Modulation Spectroscopy (MMS) of active and inactive biosimilars

Overview

Quality by Design (QbD) focuses on building good molecular design into the developmental process to prevent later stage structural problems to best establish viability of the future candidate. This reduces risk, through a better understanding of the product and enables easier formulation, development and manufacturing. QbD can also help a drug product's safety by removing known structural weaknesses that are related immunogenic issues. A critical aspect is the structural understanding, and how a protein's solution state alters as a consequence of environmental factors, e.g. that result in changes in secondary structure. Historically, in biophysical characterization studies investigating proteins with buffer additives at both high and low concentrations, scientists had to employ multiple techniques (e.g. SAXS, FTIR, DSC, SEC, XRD, NMR and UV-CD). This webinar presents data from Biokit (one of the top references in the IVD industry for the research, development and manufacturing of diagnostic solutions worldwide) that demonstrates the ability of Microfluidic Modulation Spectroscopy (MMS) to distinguish changes between protein preparations without the limitations of traditional technologies.

Biokit will present how MMS enables identification of viable raw material candidates for Latex-based diagnostic assay manufacturing. They will demonstrate the benefits of Microfluidic Modulation Spectroscopy in a Quality control (QC) environment, and for Biosimilar Higher Order Structure (HOS) studies. The data concludes that MMS provided automated, very high data quality that allowed the comparability of proteins in a QC work-flow.

Very small changes in protein secondary structure are extremely challenging to measure confidently/reproducibly using traditional spectroscopic technologies, particularly in complex buffers or samples containing additives. In this study, Microfluidic Modulation Spectroscopy enabled very small differences in secondary structure to be measured. As a result, Biokit identified which raw material from different suppliers/preparations would be most viable to be used for a Biokit Latex assay manufacturing.

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