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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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

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

Novartis’s Cosentyx® receives positive CHMP opinion for treating polymyalgia rheumatica


Lunsumio plus lenalidomide improves progression free survival in Phase III follicular lymphoma trial


FDA approves Lilly’s once weekly Onswik insulin for adults with type 2 diabetes


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Upcoming Webinars

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Past Webinars

Single-Use Chromatography – a Feasible Unit Operation?

Presented by Dr. Joachim Walter & Dr. Günter Jagschies
02nd July 2015


Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


Designer Sterile Filtration in Aseptic Processing Using Single Use Technology

Presented by Alan Kelly, Project Engineer at Sanofi and Terri Love, Senior BioManufacturing at Merck
10th November 2020


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