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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Changing Column Packing from an Art into a Science

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Headline News

mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


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Upcoming Webinars

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Past Webinars

Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories and Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc
09th September 2021


Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services
24th September 2020


The Journey to Lean Implementation for Efficiency Increase

Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
04th September 2019


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