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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

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

Monica Cardona and Ian Johnson Pall Life Sciences

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

Continuous processing optimization with smarter tools

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

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

Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Lilly and Hims & Hers expand access to Zepbound and Foundayo


Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


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Upcoming Webinars

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Past Webinars

Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development and manufacturing scale up

Presented by Sanjeev Gupta, Ph.D., Vice President and Head Advanced Biotech (Biosimilar Division), Ipca Laboratories Ltd., Mumbai-India
15th November 2022


Commercial Cell Therapy Experience Using Mycoplasma NAT For Product Release: Five-Year Review

Presented by John Duguid, Executive Director, Research & Development at Vericel Corporation and Lori Daane, Pharma Microbiology Sr. Scientific Director at bioMérieux and Mike Brewer, Director, Global Principal Consultant, Regulatory, BioProduction at Thermo Fisher Scientific
01st November 2022


Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


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