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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Enabling Total Biopharma Solutions

Pall Life Sciences

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

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

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Headline News

Regeneron’s Pasatru shows no new bone lesions in adult FOP patients between weeks 56 and 84 of OPTIMA


Astellas to present 21 oncology abstracts at ESMO 2026, with long term PADCEV plus pembrolizumab bladder cancer data and zolbetuximab research in gastric cancer


Abbott’s Cologuard screening linked to fewer colorectal cancer cases and lower risk of death in new real world data


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Upcoming Webinars

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Past Webinars

FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 2019


Lipid Based Drug Delivery Systems

Presented by Prof. Thomas Rades and Dr. Anette Müllertz, from the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen
20th November 2014


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


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