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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

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

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


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


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


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Upcoming Webinars

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Past Webinars

The Common Road to Quality for Single Use Materials

Presented by Trishna Ray-Chaudhuri, PhD, Principal Technical Manager, Genentech- A Member of the Roche Group and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Marcus Bayer, Market Segment Manager Single Use at Hamilton
21st April 2021


Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis

Presented by John-David McElderry, Scientist at Biogen and Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo International, Inc
04th March 2020


Mapping Future Technology Needs For Real Time Release Testing

Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb
09th August 2019


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