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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

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

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

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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Headline News

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


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


Lilly and Hims & Hers expand access to Zepbound and Foundayo


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Upcoming Webinars

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Past Webinars

Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020


The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability through Small Footprint, Modular Equipment Trains

Presented by Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc.
10th October 2017


Raw Material Sourcing and Qualification

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
23rd November 2020


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