An exercise in comparability: Using multi-detection SEC to evaluate the biosimilarity of monoclonal antibody biotherapeutic products

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00:00:00 Welcome
00:00:16 Introduction
00:00:54 An exercise in comparability: Using multi-detection SEC to evaluate the biosimilarity of monoclonal antibody biotherapeutic products
00:01:04 Outline
00:01:43 Size Exclusion Chromatography
00:03:13 What can SEC provide scientists?
00:05:22 Single detector SEC
00:05:27 Advantages and limitations for Conventional SEC
00:07:04 Multi-detection SEC
00:07:58 The multi-detection pyramid
00:08:05 Static Light Scattering
00:09:11 Light Scattering Theory
00:09:53 Angular dissymmetry
00:12:19 RALS/LALS and MALS
00:14:35 For more information ……
00:15:01 Malvern SEC range
00:16:22 OMNISEC
00:17:45 Outline
00:17:55 BSA Molecular weight using OMNISEC
00:20:47 Repeat injections of BSA injections
00:21:30 Single detector vs multi detector: IgG
00:22:27 Multi detector – Human and Sheep IgG
00:24:11 Biosimilars
00:24:16 Biosimilars
00:25:25 Bevacizumab (Avastin®) - Innovator
00:26:28 Bevacizumab - Biosimilar
00:27:14 Bevacizumab Innovator and Biosimilar
00:28:16 Impact of Formulation Conditions on mAb stability
00:29:20 Biosimilars - Stress testing
00:29:26 Bevacizumab – Biosimilar stress testing
00:30:21 Bevacizumab – stress testing – RI
00:31:48 Bevacizumab – stress testing – RALS
00:32:27 Denosumab – Stress testing
00:34:06 Denosumab Stress testing
00:34:39 Denosumab Stress testing
00:35:27 Conclusions
00:35:58 Untitled
00:36:03 Thank you for your attentionAny questions?
00:40:05 Contact Information
A successful biosimilar program has comparative analytical data at its foundation. As part of the analytical study, regulators require the use of state-of-the-art technology to compare the innovator and biosimilar higher order structures, including aggregation, in addition to any formulation effects on purity, stability, and product- and process-related impurities. Multi-detection SEC is a key tool in demonstrating biosimilarity, as it allows the absolute molecular weight, oligomeric state, purity and size of a monoclonal antibody to be measured in a single injection.

This webinar will present comparative SEC data collected using Malvern's OMNISEC system on a number of innovator monoclonal antibodies and biosimilar molecules, and discusses the impact of different formulations and external stress conditions on these products.


John Stenson - Product Technical Specialist for SEC.
John works as Malvern's Product Technical Specialist for our size exclusion chromatography (SEC) -related detector systems, including our OMNISEC and Viscotek product lines. John's key interest lies in using Malvern technologies to investigate the properties of proteins and biopolymers.

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Who should attend?
Formulation scientists, Biosimilar scientists, Lab Managers, R&D Scientists

What will you learn?
This webinar will provide an understanding of how multi-detection SEC can be used to create robust comparability profiles of monoclonal antibodies and their biosimilar molecules.