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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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

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

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Headline News

RYZ101 slows disease progression in Phase 3 ACTION-1 interim analysis for gastroenteropancreatic neuroendocrine tumours


Viatris agrees to acquire Pacira BioSciences for $1.65 billion to add Exparel and Zilretta


Teva’s ecopipam shows rapid and sustained tic reduction in children with Tourette syndrome in new data presented at MDS 2026


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Upcoming Webinars

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Past Webinars

Do Extractable Protocols Truly Help – An End User Perspective

Presented by Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA, Darmstadt Germany
08th May 2019


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


We Are Going Back to the Future with Rapid Methods.

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux
14th February 2022


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