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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...

Amsphere A3

JSR Life Sciences



Headline News

FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


Novo Nordisk secures exclusive global license from Hengrui Pharma for once-weekly oral GLP-1/GIP dual agonist HRS-1596


Alexion strengthens research leadership in gMG care with new data at 2026 AANEM Annual Meeting and MGFA Scientific Session


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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


Laboratory 4.0 Digitalization and IoLT (Internet of Laboratory Things) Strategies to Enrich Industry 4.0

Presented by Terryl Kibodeaux, Director, IT-Business Relationship Management (BRM) Regeneron Pharmaceuticals, Inc. and Aimee Balkenende, Senior Manager, Technical Sales at Thermo Fisher Scientific
10th June 2021


Fully continuous biosimilar manufacturing framework: A case study

Presented by Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
14th June 2018


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