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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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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

Changing Column Packing from an Art into a Science

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

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Headline News

Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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


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Upcoming Webinars

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Past Webinars

CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy

Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest
23rd March 2022


Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing

Presented by Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen and David Gemmell Senior Process Engineer at Merck
17th October 2019


Transformation of Toxicology data into Specific PDE’s

Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 2020


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