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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 review of Novo Nordisk’s denecimig for haemophilia A runs longer as manufacturing facility remediation continues


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


Epcoritamab plus R-CHOP significantly improves progression free survival in newly diagnosed diffuse large B-cell lymphoma


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Upcoming Webinars

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Past Webinars

Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River
07th October 2019


Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020


In-line monitoring of surfactant clearance in viral vaccine downstream processing

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
15th February 2022


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