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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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

Pall Corporation

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

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Headline News

Novo Nordisk secures exclusive global license from Hengrui Pharma for once-weekly oral GLP-1/GIP dual agonist HRS-1596


Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


Pfizer to showcase new cancer research spanning current standards of care and emerging pipeline breakthroughs at ESMO 2026


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Upcoming Webinars

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Past Webinars

Use of Computational Modelling in Specification Setting and Establishing Control Strategy

Presented by Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd
15th July 2019


CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 2022


Shortages of critical raw materials and managing changes and substitutions

Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022


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