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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

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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

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

Regeneron CIDEBsiRNA delivers up to 80% liver fat reduction in early MASLD study


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


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


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Upcoming Webinars

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Past Webinars

Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
25th March 2019


Mycoplasma Testing: Past, Current, and Future State

Presented by Kenneth Tai, Senior Manager, Analytical Science and Technology at Kite Pharma, Lori Daane, Pharma Microbiology Scientific Director at bioMérieux and Alexander Bartes, Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control, Roche Pharma
29th April 2021


Single-Use Bioprocess Platform for Veterinary Vaccine and Biopharmaceutical Pilot-Scale Production

Presented by Francis Verhoeye, Global Pilot Operations Leader at Zoetis Inc. and Benjamin Asher Senior Product Manager – Bioproduction at Thermo Fisher
15th June 2020


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