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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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Headline News

Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Livdelzi improves ALP normalisation rates in Phase III PBC study


Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study


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Upcoming Webinars

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Past Webinars

Host Cell Protein Characterisation and Mass Spectrometry Strategies

Presented by Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR
19th February 2019


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


Pharmaceutical Forensics for Safe Manufacturing and Supply

Presented by Ravi Kalyanaraman, Director at Bristol-Myers Squibb and Jeremy Peters, Scientist at Bristol-Myers Squibb and Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific
14th June 2019


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