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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


Featured Articles

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Enabling Total Biopharma Solutions

Pall Life Sciences

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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Headline News

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


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


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Dr. Magali Roche, Sales Manager, PathoQuest, Biologics Genomic Service
16th October 2020


Designing production facilities of the future

Presented by Geoffrey Hodge, Chief Technical Officer at Unum Therapeutics and Gary M. Pigeau, Ph.D., Director - Centre for Advanced Therapeutic Cell Technologies at GE Healthcare
30th July 2019


Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen and David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
15th November 2019


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