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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...

Amsphere A3

JSR Life Sciences


Featured Articles

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


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Upcoming Webinars

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Past Webinars

Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca & Piet Christieans, PhD, Scientific Director at Nelson Lab
14th May 2020


Case Study: Biomanufacturing for Tomorrow

Presented by Marc Pompiati, Principal Scientist at Roche Diagnostics GmbH
05th November 2020


Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services
24th September 2020


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