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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

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

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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Headline News

Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


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

Development of automated chemometric platform for accelerated Raman-based model optimization in biologics

Presented by Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen and Followed by Brian Rohrback, President and CEO of Infometrix, Inc.
20th September 2021


The Use of Stability Modelling to Support Accelerated Vaccine Development & Supply

Presented by Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur, Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands), Marilena Paludi, Lead Statistician presso GSK, and Cristiana Campa, Technical R&D Advisor at GSK
16th May 2022


Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab

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


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