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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

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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

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

FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

Characterization of Subvisible Particles in Protein and Viral Vaccines

Presented by Marina Kirkitadze,Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple
21st May 2019


Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

Presented by Dr. Jimmy Li, CEO of WuXi XDC (a WuXi Biologics subsidiary)
23rd February 2022


Application of Next Generation Sequencing (NGS) Based Methods for Detection of Viral Contaminants in Biomanufacturing

Presented by Jurgen Mullberg Associate Director at Bristol Myers Squibb and Joanna Zmurko, NGS specialist at PathoQuest
21st October 2021


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