Fecha registrada: May 18 2017

Duration: 40 minutes 22 seconds

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.
Table of contents
1. Welcome
00:16
2. Introduction
00:38
3. An exercise in comparability: Using multi-detection SEC to evaluate the biosimilarity of monoclonal antibody biotherapeutic products
00:10
4. Outline
00:39
5. Size Exclusion Chromatography
01:30
6. What can SEC provide scientists?
02:09
7. Single detector SEC
00:05
8. Advantages and limitations for Conventional SEC
01:37
9. Multi-detection SEC
00:54
10. The multi-detection pyramid
00:07
11. Static Light Scattering
01:06
12. Light Scattering Theory
00:42
13. Angular dissymmetry
02:26
14. RALS/LALS and MALS
02:16
15. For more information ……
00:26
16. Malvern SEC range
01:21
17. OMNISEC
01:23
18. Outline
00:10
19. BSA Molecular weight using OMNISEC
02:52
20. Repeat injections of BSA injections
00:43
21. Single detector vs multi detector: IgG
00:57
22. Multi detector – Human and Sheep IgG
01:44
23. Biosimilars
00:05
24. Biosimilars
01:09
25. Bevacizumab (Avastin®) - Innovator
01:03
26. Bevacizumab - Biosimilar
00:46
27. Bevacizumab Innovator and Biosimilar
01:02
28. Impact of Formulation Conditions on mAb stability
01:04
29. Biosimilars - Stress testing
00:06
30. Bevacizumab – Biosimilar stress testing
00:55
31. Bevacizumab – stress testing – RI
01:27
32. Bevacizumab – stress testing – RALS
00:39
33. Denosumab – Stress testing
01:39
34. Denosumab Stress testing
00:33
35. Denosumab Stress testing
00:48
36. Conclusions
00:31
37. Untitled
00:05
38. Thank you for your attentionAny questions?
04:02
39. Contact Information
00:17