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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

Bringing the Freezing of Biopharmaceuticals in From the Cold

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

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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Headline News

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


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


Livdelzi improves ALP normalisation rates in Phase III PBC study


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Upcoming Webinars

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Past Webinars

Path to Smart Manufacturing and Intelligent Development within Industry 4.0 – Building an Integrated Sensing Strategy

Presented by Dan Hill, Associate Director, Digital Development & Analytics, Product & Technology Development at Biogen and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech and Martin Gadsby, Vice President , Optimal Industrial Technologies Ltd
20th September 2022


Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing

Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim and Dr Julia Griffen, Product Manager Transmission Raman Products, Agilent Technologies Inc.
02nd October 2020


Mass Spectrometry – an Essential Tool for Characterization of Monoclonal Antibodies during Development

Presented by Dr Wei Xu & Dr Henry Shion
03rd February 2016


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