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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Continuous processing optimization with smarter tools

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

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.

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

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


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


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Upcoming Webinars

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Past Webinars

Implementing CMC Strategies for scale-up operations in biologics manufacturing

Presented by Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX
05th October 2018


Innovative solutions from Industry 4.0

Presented by Michael May, PhD, President and CEO, CCRM at Centre For Commercialization Of Regenerative Medicine and Philip G. Vanek, PhD, General Manager, Cell and Gene Therapy Strategy at GE
10th June 2019


Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen and David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
15th November 2019


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