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

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

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

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

Coupling single-pass TFF before loading onto a chromatography sorbent

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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Headline News

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer


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


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Upcoming Webinars

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Past Webinars

Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production

Presented by Ping Wang, Director at Johnson & Johnson and Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services
23rd March 2020


Subvisible Particles Matter, Developments in Regulations and Low Volume Methods

Presented by Dr Satish K Singh, Lonza
26th July 2018


Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
23rd October 2020


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