Current Issue

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 

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


EMPAVELI reduces proteinuria and stabilises kidney function in adolescents with C3G or primary IC MPGN


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Upcoming Webinars

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Past Webinars

Quality-By-Design in Spray Drying Processes – Transfer Lab to Production

Presented by Sune Klint Andersen at Janssen Pharmaceutical Companies of Johnson & Johnson and João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione
19th February 2019


A risk based approach to continuous processing

Presented by Rob Bowen, Chair of the UK Central Region of ISPE and co-chair of the ISPE HVAC and Sustainable Facilities Community of Practice.Process Architect and Director,Facilities Integration
14th May 2015


Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
25th March 2019


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