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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

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

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

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Changing Column Packing from an Art into a Science

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

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Headline News

Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


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


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Upcoming Webinars

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Past Webinars

Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Expectations

Presented by Xin Bu, Principal Scientist at Bristol-Myers Squibb
05th February 2019


Finding the Common Road to Quality for Single-Use Materials

Presented by Dr Trishna Ray-Chaudhuri, Genentech and Dr Hélène Pora of Pall Biotech
06th June 2018


BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019


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