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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

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

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

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


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


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Upcoming Webinars

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Past Webinars

A risk based approach to continuous processing

Presented by Rob Bowen, Chair of the UK Central Region of ISPE and co-chair of the ISPE HVAC and Sustainable Facilities Community of Practice.Process Architect and Director,Facilities Integration
14th May 2015


Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay

Presented by Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX
28th June 2018


Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing – A Reality Check

Presented by Joachim Walter
08th February 2018


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