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
Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA
Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing
Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.
Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
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FDA approves Rhapsido as first treatment for symptomatic dermographism
FDA accepts Bayer application for finerenone in chronic kidney disease without diabetes
Thermo Fisher expands drug development and manufacturing capabilities at CPHI Milan 2026
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Upcoming Webinars
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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
CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy
Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest
23rd March 2022
Mass Spectrometry – an Essential Tool for Characterization of Monoclonal Antibodies during Development
Presented by Dr Wei Xu & Dr Henry Shion
03rd February 2016
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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
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
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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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