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
Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins
Overcoming Obstacles in AAV Viral Vector Manufacturing
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
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FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold
FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks
FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
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Upcoming Webinars
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UNICAN: Dual capability in single use bioreactors
Presented by Presented by Ekta Mahajan, Senior. Regulatory Program Director at Genentech
13th October 2022
Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products
Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022
Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess
Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada and Dean Roberts, Director of Market and Technology Development, Bruker Applied Spectroscopy, North America
16th November 2021
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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
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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