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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...

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JSR Life Sciences


Featured Articles

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Changing Column Packing from an Art into a Science

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Volume Reduction and Process Optimization with Cadence Inline Concentrator

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Headline News

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


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


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


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Upcoming Webinars

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Past Webinars

How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
19th September 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


Material Understanding for Continuous Manufacturing of Solid Dosage Forms

Presented by Dr Yifan Wang, Regulatory Research Scientist, FDA CDER and Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific
23rd August 2018


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