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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


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


Trixeo approved in the EU as first triple combination maintenance therapy for asthma in patients aged 12 and older


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Past Webinars

Current Progress in Approaches for The Safety Assessment of Extractables and Leachables

Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services
06th April 2018


Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


Improving Efficiency in Upstream Process Development

Presented by Jackie Gonzalez, Senior Upstream Development Engineer at Takeda, Klaus Mauch, CEO at Insilico Biotechnology AG
01st March 2021


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