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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

Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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Past Webinars

A Data Driven Biopharmaceutical Manufacturing Facility-Plug and Produce – Shaping the Future Together

Presented by Josef Trapl Global Manufacturing & Supply, Head of MSci Innovation at Takeda and Petter Moree, Global Industry Principal at OSIsoft
04th March 2021


Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up

Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
10th March 2020


FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 2019


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