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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


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Navigating Technology Transfer

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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

Regeneron CIDEBsiRNA delivers up to 80% liver fat reduction in early MASLD study


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


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Past Webinars

Raman Spectral Library for Counterfeit Detection

Presented by Dr. Jason Rodriguez, FDA Division of Pharmaceutical Analysis (DPA) and Dr. Katherine A. Bakeev, Director of Analytical Services and Support for B&W Tek
18th March 2015


Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
24th May 2019


Quality-By-Design in Spray Drying Processes – Transfer Lab to Production

Presented by Sune Klint Andersen at Janssen Pharmaceutical Companies of Johnson & Johnson and João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione
19th February 2019


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