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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


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


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Past Webinars

Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology

Presented by Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand and Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories
28th October 2021


Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process

Presented by Oliver Steinhof, PAT Scientist at Biogen and Martin Gadsby, Owner, Optimal Industrial Automation Ltd
06th November 2020


Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing

Presented by Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche
26th September 2022


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