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

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

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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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Headline News

Alexion to present 16 abstracts on hypophosphatasia and hypoparathyroidism at ASBMR 2026 Annual Meeting


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


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


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Upcoming Webinars

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Past Webinars

Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services
24th September 2020


Advanced process development using automated micro bioreactors shortens timelines and provides process solutions for a rapid scale up

Presented by Presented by Dr. Jincai Li, Vice President of WuXi Biologics and Liang Tang, PhD, Vice President of WuXi Biologics and Sunil Chhatre, Sartorius Stedim Biotech
14th September 2018


Points to consider when defining a microbial control strategy for individualized ATMPs

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project (individualized Neoantigen Specific Therapy)
05th April 2023


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