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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 grants Priority Review to uniQure’s Huntington’s disease gene therapy


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Past Webinars

Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca & Piet Christieans, PhD, Scientific Director at Nelson Lab
14th May 2020


Qualification of Raw Materials and Cell Substrates for Biomanufacturing

Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck
16th January 2020


Final Revised Version of BioPhorum Extractable Testing Recommendation Part 2

Presented by Sara Ullsten, R&D Section Manager, Cytiva and Haiyan Hong, R&D manager of Life Sciences at Saint-Gobain
11th June 2020


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