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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


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Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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Headline News

Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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Past Webinars

Challenges In Therapeutic Biological Products

Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Dr. Sona Kovackova, Study Director Small Volume Parenteral applications, Nelson Labs Europe
18th August 2022


Rapid Microbiology Applications in the COVID-19 Era

Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020


An impurity detected in a stability study: Did we miss anything in our E&L risk assessment?

Presented by Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe
15th March 2022


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