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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

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Changing Column Packing from an Art into a Science

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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 places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

Using PAT to accelerate and optimize the process development of solid dosage forms.

Presented by Lizbeth Martinez, Ph. D. Associate Director Data Science, Oral Pharmaceutical Development at Novartis Basel Switzerland and Emiliano Genorini, Account Manager – MicroNIR at Viavi Solutions
04th November 2021


Case Study: CMC Biologics Explores the Potential of Continuous Multi-Column Chromatography

Presented by Michelle Najera, PhD, CMC Biologics, Downstream Process Development Scientist and Lynne Frick, Director of Sales, Continuous Bioprocessing, Pall Life Sciences
06th February 2017


Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020


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