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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

James Barry, Director of Marketing, Americas, Pall Biotech

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

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Headline News

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer


Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


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Upcoming Webinars

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Past Webinars

Transformation of Toxicology data into Specific PDE’s

Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 2020


Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics

Presented by Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
26th October 2020


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


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