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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

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

RYZ101 slows disease progression in Phase 3 ACTION-1 interim analysis for gastroenteropancreatic neuroendocrine tumours


Teva’s ecopipam shows rapid and sustained tic reduction in children with Tourette syndrome in new data presented at MDS 2026


Teva’s Weltruza becomes first once monthly subcutaneous olanzapine injection to win FDA approval for adults with schizophrenia


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Upcoming Webinars

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Past Webinars

Biotech Integrated Solutions – Accelerate Speed to Market

Presented by Dave Sokolowski, Global Product Manager, Integrated Solutions, Pall Corporation and Kevin Thompson, Technical Director, Pall Advanced Separation Systems (PASS), Pall Corporation
30th September 2021


From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
27th March 2019


Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings

Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson
08th February 2023


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