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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...

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JSR Life Sciences


Featured Articles

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


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


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Upcoming Webinars

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Past Webinars

Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies in Pharmaceutical Development

Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc.
01st July 2019


Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux
23rd May 2019


Manufacturing strategies for Biosimilars: A case of continuous capture

Presented by Solomon Alva, Antibody Purification Group Lead, Senior Scientific Manager, Biocon Research Limited
15th June 2018


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