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

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

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

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

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

Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer


Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


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Upcoming Webinars

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Past Webinars

Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories and Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc
09th September 2021


Single Use Process for Production of AAV Gene Therapy Products

Presented by Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics, Vikas Gupta, Vice President and GM Downstream Bioprocessing and Gene Therapy, Rachel Legmann, Senior Director of Technology, Gene Therapy at Repligen and Gilbert Huang, Senior Field Application Scientist at Repligen
26th May 2022


A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT
16th September 2020


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