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

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

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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

Pall Corporation

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


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


Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


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Upcoming Webinars

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Past Webinars

Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 2019


Extractable Study Design and Data Evaluation of Polymeric Product Contact Materials

Presented by Dr. Ping Wang, Principal Scientist, Janssen R&D and Dr Nixdorf, SGS Group
05th June 2018


Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up

Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
10th March 2020


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