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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

Livdelzi improves ALP normalisation rates in Phase III PBC study


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


Allergan Aesthetics reports improved facial satisfaction in GLP-1 users after aesthetic treatments


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Upcoming Webinars

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Past Webinars

Material Requirements to Support Gene Therapy Development

Presented by Clare Blue, Director of Analytical Development at Biogen and James Wilkinson, VP of Sales and Customer Success at Refeyn
19th May 2022


Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality

Presented by Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter, Product Line Lead, Cell Culture and Clarification Business at Repligen
25th February 2019


IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From Hype to Reality

Presented by Jun Huang, Director/Team Leader, Process Monitoring, Automation & Control at Pfizer and Amos Dor, Pharma General Manager & CTO at Applied Materials Automation Product Group
17th March 2020


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