Justifications of small scale models: an industry perspective to hear their thoughts on how it addresses the gap in industry alignment and regulatory practice

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BioPhorum introduces – addressing the gap in industry alignment and regulatory practice

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Broadcast date

Wed, Jul 14, 2021

 

Presented by

    Prasad Pathange - Bayer
    Kiran Andra - Alexion Pharmaceuticals
    Robert Luo - GlaxoSmithKline
    Joschka Buyel - Bayer

 

Quick Description

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

Details

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