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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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

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

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer


Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


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Upcoming Webinars

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Past Webinars

Mycoplasma Testing: Past, Current, and Future State

Presented by Kenneth Tai, Senior Manager, Analytical Science and Technology at Kite Pharma, Lori Daane, Pharma Microbiology Scientific Director at bioMérieux and Alexander Bartes, Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control, Roche Pharma
29th April 2021


Mass Transport Modelling in support of leachable risk management

Presented by Thomas Egert, Research Scientist Pharmaceutical Contact Materials at Boehringer Ingelheim Pharma GmbH and and Jason Creasey, Managing Director at Maven E&L Ltd
17th January 2023


The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry

Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology Center of Excellence, Technical Operations, Janssen Pharmaceuticals and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
16th March 2020


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