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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

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

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

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

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Headline News

Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


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Upcoming Webinars

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Past Webinars

The Importance of Accurate Chemical Characterization of Medical Devices Extractables

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christiaens, PhD, Scientific Director at Nelson Labs
16th November 2022


Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

Presented by Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines Followed by Klaus Mauch, CEO at Insilico Biotechnology AG and Shilpa Nargund Data Scientist and Business Development Manager at Insilico Biotechnology AG
02nd September 2019


Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody Drug Conjugates

Presented by Arnaud Delobel, PhD, R&D Director at Quality Assistance sa
12th September 2017


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