| 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.
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.
Speakers
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.
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.
More information
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.
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.