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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

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

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Headline News

Robigo raises Series A led by Leaps by Bayer to advance engineered crop protection biologicals


Körber certifies ZETA’s INOSIM Foresight for PAS X MES data integration


Trixeo approved in the EU as first triple combination maintenance therapy for asthma in patients aged 12 and older


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Upcoming Webinars

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Past Webinars

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


Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada and Dean Roberts, Director of Market and Technology Development, Bruker Applied Spectroscopy, North America
16th November 2021


Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


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