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

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Changing Column Packing from an Art into a Science

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

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

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


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


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Upcoming Webinars

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Past Webinars

Efficient execution of biologics manufacturing – The role of Finite Scheduling systems as part of sound business process from planning to floor operations.

Presented by Gloria Gadea-Lopez, Ph.D., John Maguire and Megan Rabideau
14th February 2018


Extractables and leachables testing using a Quality Risk Management approach

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer and Satish Kumar Mohanvelu, Life Sciences Management Professional at MilliporeSigma
17th October 2018


Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Justin Moretto, Life Science Product Marketing Manager at Kaiser Optical Systems, Inc
06th September 2021


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