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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...

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JSR Life Sciences


Featured Articles

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

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Headline News

TECVAYLI plus DARZALEX FASPRO modelling suggests longer survival in early line relapsed multiple myeloma


Novartis’s Cosentyx® receives positive CHMP opinion for treating polymyalgia rheumatica


Robigo raises Series A led by Leaps by Bayer to advance engineered crop protection biologicals


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Upcoming Webinars

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Past Webinars

Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada and Dean Roberts, Director of Market and Technology Development, Bruker Applied Spectroscopy, North America
16th November 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


Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022


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