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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 

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

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

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

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Past Webinars

Smart machine learning solution to master industry 4.0 in biopharma

Presented by Moritz von Stosch, PhD,
11th November 2020


Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing

Presented by Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche
26th September 2022


BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019


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