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
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.
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma
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
Headline News
FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting
Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study
Jemperli achieves 76% complete response rate in Phase II rectal cancer trial
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Upcoming Webinars
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Biopharmaceutical process development – Trends/ Challenges/Opportunities
Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech
20th November 2019
Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Purification Optimisation
Presented by Dr Li Zang of Biogen
31st October 2017
Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings
Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson
08th February 2023
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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
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
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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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