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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


Featured Articles

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

Sanofi and Regeneron bring four new long acting antibodies into Dupixent partnership in deal worth up to $8 billion


Ubamatamab produces high rate of durable responses in early study of advanced low grade serous ovarian cancer


AstraZeneca finalises $2 billion stake in Summit Therapeutics to speed up ivonescimab combination research


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Upcoming Webinars

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Past Webinars

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


Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 2019


Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
24th May 2019


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