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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

James Barry, Director of Marketing, Americas, Pall Biotech

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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


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Upcoming Webinars

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Past Webinars

Extractables from Single-Use Bioreactors/Bags and Impact on Cell Culture Performance

Presented by Yasser Nashed-Samuel, Principal Scientist at Amgen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
22nd January 2019


Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

Presented by Robert Dream, PE, CPIP, of HDR Company, LLC
19th July 2017


Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Justin Moretto, Life Science Product Marketing Manager at Kaiser Optical Systems, Inc
06th September 2021


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