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

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

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

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.

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

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Headline News

Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


Allergan Aesthetics reports improved facial satisfaction in GLP-1 users after aesthetic treatments


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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Upcoming Webinars

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Past Webinars

Big Data Strategies for Cell Therapy Manufacturing

Presented by Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc
17th September 2019


Just in Time Release of CAR T Cell Therapies During Covid-19

Presented by Irving Ford, Site QA Head multi-product CAR T facility at Bristol Myers Squibb and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
29th November 2021


Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


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