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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

Navigating Technology Transfer

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

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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


Livdelzi improves ALP normalisation rates in Phase III PBC study


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Upcoming Webinars

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Past Webinars

Compression of film-coated pellets – key parameters for optimal tablet quality

Presented by Karl G. Wagner, Professor in Pharmaceutical Technology at the University of Bonn
04th March 2015


An Investigation into Integration of Disposable Components into Traditional Stainless-steel Facilities

Presented by Ron Bates, Bristol-Myers Squibb and Miriam Monge, Sartorius Stedim biotech Integrated Solutions
22nd May 2018


Risk Assessment of Extractables and Leachables in Different Phases of Development.

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Ward d’Autry, Study Director E/L & Structural Elucidation, Nelson Labs Europe
22nd April 2021


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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

Strategy Emerging Markets for Risk Mitigation


Best Practices for Achieving Virus Safety


Column Packing Protocol for Amsphere A3


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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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