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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  

Bringing the Freezing of Biopharmaceuticals in From the Cold

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L 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

Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


Allergan Aesthetics reports improved facial satisfaction in GLP-1 users after aesthetic treatments


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


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Upcoming Webinars

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Past Webinars

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

Presented by Kathryn McGohan, Bristol-Myers Squibb and Dr Hélène Pora and Dr James Hathcock of Pall Biotech
20th March 2018


Challenges Faced by the End Users During the Qualification of Single Use System

Presented by Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager / Business Development Manager R&D at SGS Group
14th January 2019


Is India Anywhere Closer to Implementing Continuous Bioprocessing

Presented by Narasimha Rao Nedunuri, Managing Director of CLONZ and José Castillo, PhD, CTo and co-founder of Univercells
16th August 2018


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