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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

Navigating Technology Transfer

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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Headline News

FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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


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Upcoming Webinars

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Past Webinars

Mycoplasma Testing: Past, Current, and Future State

Presented by Kenneth Tai, Senior Manager, Analytical Science and Technology at Kite Pharma, Lori Daane, Pharma Microbiology Scientific Director at bioMérieux and Alexander Bartes, Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control, Roche Pharma
29th April 2021


Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process

Presented by Oliver Steinhof, PAT Scientist at Biogen and Martin Gadsby, Owner, Optimal Industrial Automation Ltd
06th November 2020


A Hybrid Approach to Continuous Biomanufacturing of Biosimilars

Presented by Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech
19th January 2023


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