Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by

Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech

About this talk

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd Current trends and regulation affecting Biopharmaceutical Industry Journey from Lab scale to Commercial –Overcoming Scalability design hurdles QbD-Bringing Improvements in Biologics development and Manufacturing Space Followed by Quality by Design (QbD) Approach for a Virus Filtration Application Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies. A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.

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