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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

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Changing Column Packing from an Art into a Science

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Headline News

Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


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Upcoming Webinars

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Past Webinars

Fully continuous biosimilar manufacturing framework: A case study

Presented by Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
14th June 2018


Analytical Challenges for Gene Therapy

Presented by Clare Blue, Director of Analytical Development at Biogen and Saba Hussein, Applications Manager and Senior Scientist at Vironova
03rd November 2020


Single-Use-Systems: Leachable Study Design for Single-Use Components

Presented by Kathryn McGohan, Bristol-Myers Squibb and Dr Hélène Pora and Dr James Hathcock of Pall Biotech
20th March 2018


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