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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

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

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


Lilly highlights retatrutide, Taltz and Zepbound data across rheumatologic diseases and obesity


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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


Advanced process development using automated micro bioreactors shortens timelines and provides process solutions for a rapid scale up

Presented by Presented by Dr. Jincai Li, Vice President of WuXi Biologics and Liang Tang, PhD, Vice President of WuXi Biologics and Sunil Chhatre, Sartorius Stedim Biotech
14th September 2018


Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River
07th October 2019


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