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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

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Headline News

Robigo raises Series A led by Leaps by Bayer to advance engineered crop protection biologicals


Lunsumio plus lenalidomide improves progression free survival in Phase III follicular lymphoma trial


FDA approves Kerendia for chronic kidney disease linked to type 1 diabetes


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Upcoming Webinars

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Past Webinars

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


Just in Time Release of CAR T Cell Therapies

Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
11th November 2019


Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release

Presented by John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River
08th November 2018


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