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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

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

Monica Cardona and Ian Johnson Pall Life Sciences

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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

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Headline News

FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


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Upcoming Webinars

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Past Webinars

Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1

Presented by Frances Sexton, Carsten Worsøe, Ken Wong, and Satish Kumar
18th May 2020


Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


Big Data Strategies for Cell Therapy Manufacturing

Presented by Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc
17th September 2019


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