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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

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

Navigating Technology Transfer

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

Continuous processing optimization with smarter tools

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

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Headline News

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study


Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines


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Upcoming Webinars

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Past Webinars

Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

Presented by Miriam Guest, New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK and Ulrich Herber Senior Director of Technology and Market Development at Charles River
12th January 2022


Implementing CMC Strategies for scale-up operations in biologics manufacturing

Presented by Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX
05th October 2018


Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Processing of Monoclonal Antibodies from CHO Cell Cultures

Presented by Brian O' Mara, Senior Research Scientist I at Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist at 3M Separation and Purification Sciences Division
08th October 2018


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