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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
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
Overcoming Obstacles in AAV Viral Vector Manufacturing
Continuous processing optimization with smarter tools
Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific
Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies
James Barry, Director of Marketing, Americas, Pall Biotech
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Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study
mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults
Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial
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Upcoming Webinars
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Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab
Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT
25th January 2019
Validation of Microbiological Methods – Expectations for Regulatory Compliance
Presented by Dr. Rajesh K. Gupta Scientific & Compliance Consultant and Alan Hoffmeister, Global Field Technical Manager for Charles River
22nd May 2015
CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy
Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest
23rd March 2022
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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
Rationale Design of Valves for Flexible Processing
Strategy Emerging Markets for Risk Mitigation
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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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