Current Issue

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

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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

Bristol Myers Squibb adds $1 million community grant programme to second year of Champions in Care campaign


Ubamatamab produces high rate of durable responses in early study of advanced low grade serous ovarian cancer


AstraZeneca opens $1 billion global research centre in Cambridge Massachusetts that will lift its local workforce by more than 50 per cent


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Upcoming Webinars

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Past Webinars

Vaccine Development & its Manufacturing using Integrated High Throughput Technology

Presented by Dr. S.K. Jana, Director - R&D and Manufacturing, Human Vaccine Development, Serum Institute of India Pvt. Ltd. and Vikas Revankar, Head of Product Management and Marketing - Digital Portfolio, BioContinuum™ Platform - Merck and Piergiuseppe Nestola, PhD Global Vaccine Technology Consultant at Sartorius
20th September 2021


Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
25th March 2019


Qualification of Raw Materials and Cell Substrates for Biomanufacturing

Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck
16th January 2020


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