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



Headline News

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


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Upcoming Webinars

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Past Webinars

Advanced process development using automated micro bioreactors shortens timelines and provides process solutions for a rapid scale up

Presented by Presented by Dr. Jincai Li, Vice President of WuXi Biologics and Liang Tang, PhD, Vice President of WuXi Biologics and Sunil Chhatre, Sartorius Stedim Biotech
14th September 2018


Use of Computational Modelling in Specification Setting and Establishing Control Strategy

Presented by Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd
15th July 2019


Implementing CMC Strategies for scale-up operations in biologics manufacturing

Presented by Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX
05th October 2018


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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.

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

 

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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


Amsphere TM A3


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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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