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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


Astellas begins Phase III trial of setidegrasib in KRAS G12D mutated advanced lung cancer


FDA approves Lilly’s Olumiant for adolescents with severe alopecia areata


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Past Webinars

Continuous Manufacturing of Biologics: A Journey from Concept to Reality

Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
15th September 2021


Mapping Future Technology Needs For Real Time Release Testing

Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb
09th August 2019


New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

Presented by Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC
23rd August 2017


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