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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

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Headline News

Admilparant meets primary endpoint at 60 mg dose in Phase 3 ALOFT-IPF trial for idiopathic pulmonary fibrosis


Efzimfotase alfa misses statistical significance on primary walking endpoint but improves fatigue in adolescents and adults with hypophosphatasia in HICKORY Phase III trial


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


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Upcoming Webinars

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Past Webinars

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


Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca & Piet Christieans, PhD, Scientific Director at Nelson Lab
14th May 2020


Continuous Manufacturing of Biologics: A Journey from Concept to Reality

Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
15th September 2021


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