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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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  

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

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Headline News

Lilly and Hims & Hers expand access to Zepbound and Foundayo


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


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Upcoming Webinars

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Past Webinars

Future Trends To Control Risks From Extractables and Leachables

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe
09th February 2021


Shortages of critical raw materials and managing changes and substitutions

Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022


Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River
07th October 2019


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