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  

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.

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

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

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Headline News

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


Novo Nordisk and Anthropic to team up on accelerating drug discovery through Claude


Körber certifies ZETA’s INOSIM Foresight for PAS X MES data integration


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Upcoming Webinars

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Past Webinars

End User Perspective on Setting in-Process Endotoxin Limits

Presented by Dr Friedrich von Wintzingerode, Roche/Genentech
15th May 2018


Single-Use Chromatography – a Feasible Unit Operation?

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


Operational Excellence in Process Development in Drug Substance Production

Presented by Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics, Klaus Mauch, CEO at Insilico Biotechnology AG
11th February 2021


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