Addressing the gap in industry alignment and regulatory practice

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’sSmall 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. PrasadPathange, 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.