BioPhorum introduces – addressing the gap in industry alignment and regulatory practice
Broadcast date
Wed, Jul 14, 2021
Presented by
- Prasad Pathange - BayerKiran Andra - Alexion PharmaceuticalsRobert Luo - GlaxoSmithKlineJoschka Buyel - Bayer
Quick description
Small-scale models and their qualification are important steps of biopharmaceutical process development, characterization, and validation. Despite being required by regulatory bodies, there is no guidance on current best practices and companies use many different qualification approaches throughout the industry.
In this podcast, we hear from some of the lead authors from BioPhorum’s Small Scale Models Workstream who contributed to the article Justifications of small scale models: an industry perspective to hear their thoughts on how it addresses the gap in industry alignment and regulatory practice. Prasad Pathange, Director at Bayer, Kiran Andra, Development Scientist at Alexion Pharmaceuticals, Robert Luo, Scientific Director and Downstream Process Development at GlaxoSmithKline, and Joschka Buyel, Process and Knowledge Management Scientist at Bayer discuss what they think about the current situation and their thoughts for the future.
Speakers
Prasad Pathange
Director
Bayer
Kiran Andra
Development Scientist
Alexion Pharmaceuticals
Robert Luo
Scientific Director and Downstream Process Development
GlaxoSmithKline
Joschka Buyel
Process and Knowledge Management Scientist
Bayer