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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
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Changing Column Packing from an Art into a Science
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies
Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington
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Robigo raises Series A led by Leaps by Bayer to advance engineered crop protection biologicals
Lunsumio plus lenalidomide improves progression free survival in Phase III follicular lymphoma trial
Novartis’s Cosentyx® receives positive CHMP opinion for treating polymyalgia rheumatica
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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
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
Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis
Presented by John-David McElderry, Scientist at Biogen and Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo International, Inc
04th March 2020
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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
Rationale Design of Valves for Flexible Processing
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
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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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