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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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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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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Featured Companies
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Featured Video
At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.
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Technical Papers
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
Strategy Emerging Markets for Risk Mitigation
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Featured Products
Decrease Cleaning Validation Time and Resources
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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