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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
JSR Life Sciences
Featured Articles
Enabling Total Biopharma Solutions
Pall Life Sciences
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies
James Barry, Director of Marketing, Americas, Pall Biotech
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.
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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
Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis
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Upcoming Webinars
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Case Study: An End-to-End Solution for Large Scale Adenovirus Manufacturing
Presented by Clive Glover, PhD, Senior Marketing Manager, Cell & Gene Therapy at Pall and Rachel Legmann, PhD, Senior Manager, Process Development Services at Pall
13th November 2018
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
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
Presented by Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter, Product Line Lead, Cell Culture and Clarification Business at Repligen
25th February 2019
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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
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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