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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

Navigating Technology Transfer

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


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Upcoming Webinars

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Past Webinars

New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany
09th April 2019


Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab

Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT
25th January 2019


Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings

Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson
08th February 2023


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