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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

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

Livdelzi improves ALP normalisation rates in Phase III PBC study


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


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Upcoming Webinars

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Past Webinars

Lessons Learned and Benefits Gained from the Global Implementation of an Automated Endotoxin Testing Solution

Presented by Dennis Wong, Global QC Technical Lead, Global Quality Control, Operations, AstraZeneca Liverpool UK
09th March 2023


Towards Real Time Release testing: Dissolution prediction of tablets made using Continuous Direct Compression

Presented by Pallavi Pawar of GlaxoSmithKline
21st November 2017


Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis

Presented by John-David McElderry, Scientist at Biogen and Dominique Hebrault, Science & Technology Business Development at Mettler-Toledo International, Inc
04th March 2020


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