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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

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

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Headline News

Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


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Upcoming Webinars

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Past Webinars

Use of Computational Modelling in Specification Setting and Establishing Control Strategy

Presented by Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd
15th July 2019


Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies in Pharmaceutical Development

Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc.
01st July 2019


The Common Road to Quality for Single Use Materials

Presented by Trishna Ray-Chaudhuri, PhD, Principal Technical Manager, Genentech- A Member of the Roche Group and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Marcus Bayer, Market Segment Manager Single Use at Hamilton
21st April 2021


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