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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 

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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

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


Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal 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

Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells

Presented by Jon Rowley, Ph.D. & Mark Szczypka, Ph.D.
28th March 2017


Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing

Presented by Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche
26th September 2022


Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories and Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc
09th September 2021


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