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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...

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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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Navigating Technology Transfer

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Roche receives CE Mark for compact cobas smart e immunoanalyser


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Past Webinars

UNICAN: Dual capability in single use bioreactors

Presented by Presented by Ekta Mahajan, Senior. Regulatory Program Director at Genentech
13th October 2022


Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


Pharmaceutical Manufacturing in the 21st Century-From Batch to Continuous Manufacturing-An FDA Perspective

Presented by Dr Sau (Larry) Lee, FDA
15th June 2016


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