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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


Featured Articles

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

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

Changing Column Packing from an Art into a Science

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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Headline News

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


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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Upcoming Webinars

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Past Webinars

Innovation in Biomanufacturing Plants

Presented by Hang Zhou, Ph.D., Vice President, Head of Cell Culture Process Development Biologics and Bioprocess Dept. at WuXi Biologics and Earl Pineda, Senior Manager, Field Applications at Repligen, Europe
10th November 2020


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


Platform technology development for biosimilar upscaling

Presented by Dr H. Fai Poon, President, QuaCell Biotech Ltd and Floris De Smet, Sartorius Stedim Biotech
21st June 2018


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