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

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


Roche receives CE Mark for compact cobas smart e immunoanalyser


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Upcoming Webinars

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Past Webinars

Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing within Industry 4.0

Presented by Robert Guenard, Senior Director - Manufacturing Sciences at Biogen, Petter Moree, Global Industry Principal at OSIsoft and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
13th November 2020


Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Purification Optimisation

Presented by Dr Li Zang of Biogen
31st October 2017


Control Strategy and a Real Time Release Testing From a Development Line to Commercial Manufacturing

Presented by Tom Van Den Kerkhof Scientist at Johnson & Johnson and Sebastian Sowinski Key Account Manager at Sentronic
25th March 2020


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