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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Navigating Technology Transfer

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

James Barry, Director of Marketing, Americas, Pall Biotech

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Headline News

FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


AstraZeneca commits $2 billion to Summit Therapeutics as part of new equity stake and cancer research alliance centered on antibody drug conjugate combinations


Alexion strengthens research leadership in gMG care with new data at 2026 AANEM Annual Meeting and MGFA Scientific Session


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Upcoming Webinars

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Past Webinars

Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing within Industry 4.0

Presented by Robert Guenard, Senior Director - Manufacturing Sciences at Biogen, Petter Moree, Global Industry Principal at OSIsoft and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
13th November 2020


Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology

Presented by Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand and Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories
28th October 2021


Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


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