Current Issue

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

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

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 

Enabling Total Biopharma Solutions

Pall Life Sciences

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Headline News

Lilly highlights retatrutide, Taltz and Zepbound data across rheumatologic diseases and obesity


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


Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study


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Upcoming Webinars

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Past Webinars

Single Use Systems in Biologics Manufacturing and their Impact on Operational Technology

Presented by Gloria Gadea-Lopez, PhD, John Maguire & Mark Maselli of Shire followed by Ken Clapp of GE Healthcare
04th April 2017


Lessons Learned and Benefits Gained from the Global Implementation of an Automated Endotoxin Testing Solution

Presented by Dennis Wong, Global QC Technical Lead, Global Quality Control, Operations, AstraZeneca Liverpool UK
09th March 2023


Risk Assessment of Extractables and Leachables in Different Phases of Development.

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Ward d’Autry, Study Director E/L & Structural Elucidation, Nelson Labs Europe
22nd April 2021


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