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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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Navigating Technology Transfer

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Headline News

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


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Lilly highlights retatrutide, Taltz and Zepbound data across rheumatologic diseases and obesity


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Upcoming Webinars

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Past Webinars

BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019


Extractable and Leachable Study Design For Disposables

Presented by Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables at Sanofi Pasteurand Jerry Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences
11th February 2015


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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