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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



Headline News

Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


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Upcoming Webinars

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Past Webinars

The Business Benefits of PAT in Continuous Drug Product Manufacturing

Presented by Steve Hammond, Independent Consultant at Steve Hammond Consulting
22nd September 2021


Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020


FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 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.

There’s no kit for the perfect biotech process. Until now.

 

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Technical Papers

Amsphere TM A3


Rationale Design of Valves for Flexible Processing


Lifetime study for JSR Amsphere A3 – protein A resin


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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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