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
Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA
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
Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor
Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma
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Efzimfotase alfa misses statistical significance on primary walking endpoint but improves fatigue in adolescents and adults with hypophosphatasia in HICKORY Phase III trial
Regeneron’s Pasatru shows no new bone lesions in adult FOP patients between weeks 56 and 84 of OPTIMA
Astellas to present 21 oncology abstracts at ESMO 2026, with long term PADCEV plus pembrolizumab bladder cancer data and zolbetuximab research in gastric cancer
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Upcoming Webinars
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Subvisible Particle Identification & Characterisation by Multi-Technique Methods
Presented by Dr. Jonas Hoeg Thygesen, Novo Nordisk Pharmatech. Followed by Colin Merrifield, ProteinSimple
23rd February 2017
BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities
Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019
Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model
Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 2019
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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
Lifetime study for JSR Amsphere A3 – protein A resin
Amsphere TM A3
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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