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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
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Featured Articles
Enabling Total Biopharma Solutions
Pall Life Sciences
Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor
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Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial
FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold
FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
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Upcoming Webinars
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Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing
Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim and Dr Julia Griffen, Product Manager Transmission Raman Products, Agilent Technologies Inc.
02nd October 2020
Extractable and Leachable Study Design For Disposables
Presented by Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables at Sanofi Pasteurand Jerry Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences
11th February 2015
Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
Presented by Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX
28th June 2018
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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
Lifetime study for JSR Amsphere A3 – protein A resin
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
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Decrease Cleaning Validation Time and Resources
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Amsphere™ A3 Protein A Resin – JSR Life Sciences
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