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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

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

James Barry, Director of Marketing, Americas, Pall Biotech

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

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

Monica Cardona and Ian Johnson Pall Life Sciences

Navigating Technology Transfer

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Headline News

Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


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Upcoming Webinars

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Past Webinars

Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

Presented by Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines Followed by Klaus Mauch, CEO at Insilico Biotechnology AG and Shilpa Nargund Data Scientist and Business Development Manager at Insilico Biotechnology AG
02nd September 2019


Qualification of Raw Materials and Cell Substrates for Biomanufacturing

Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck
16th January 2020


Advanced process development using automated micro bioreactors shortens timelines and provides process solutions for a rapid scale up

Presented by Presented by Dr. Jincai Li, Vice President of WuXi Biologics and Liang Tang, PhD, Vice President of WuXi Biologics and Sunil Chhatre, Sartorius Stedim Biotech
14th September 2018


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