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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 approves Abbott’s Amplatzer Paraclose device for heart valve leaks


Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


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


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Past Webinars

BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019


Mass Spectrometry – an Essential Tool for Characterization of Monoclonal Antibodies during Development

Presented by Dr Wei Xu & Dr Henry Shion
03rd February 2016


Big Data Strategies for Cell Therapy Manufacturing

Presented by Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc
17th September 2019


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