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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

Teva’s Weltruza becomes first once monthly subcutaneous olanzapine injection to win FDA approval for adults with schizophrenia


Abbott’s Cologuard screening linked to fewer colorectal cancer cases and lower risk of death in new real world data


Admilparant meets primary endpoint at 60 mg dose in Phase 3 ALOFT-IPF trial for idiopathic pulmonary fibrosis


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Upcoming Webinars

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Past Webinars

Efficiency by Design – Case Study for a Hybrid Clinical Manufacturing Facility

Presented by Dr Sourav Kundu, Senior Director, Process Development and Clinical manufacturing at Teva Pharmaceuticals and Adam Kaletski, Business Leader, Bioprocess Hardware and Enterprise Solutions at GE Healthcare
09th November 2018


Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Justin Moretto, Life Science Product Marketing Manager at Kaiser Optical Systems, Inc
06th September 2021


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


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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


Lifetime study for JSR Amsphere A3 – protein A resin


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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