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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


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


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Do Extractable Protocols Truly Help – An End User Perspective

Presented by Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA, Darmstadt Germany
08th May 2019


Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

Presented by Dr. Jimmy Li, CEO of WuXi XDC (a WuXi Biologics subsidiary)
23rd February 2022


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

Presented by Kathryn McGohan, Bristol-Myers Squibb and Dr Hélène Pora and Dr James Hathcock of Pall Biotech
20th March 2018


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