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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

Coupling single-pass TFF before loading onto a chromatography sorbent

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

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

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Headline News

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


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


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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Upcoming Webinars

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Past Webinars

Continuous Capture and Continuous Recovery – Novel Ideas for Product Recovery from Perfusion Process Using ATF

Presented by Dr. Kerstin Lange, Team Lead Process Technology and Innovation, Advanced Bioprocessing, Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech and Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC at Repligen
03rd February 2021


The Use of Stability Modelling to Support Accelerated Vaccine Development & Supply

Presented by Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur, Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands), Marilena Paludi, Lead Statistician presso GSK, and Cristiana Campa, Technical R&D Advisor at GSK
16th May 2022


Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


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