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

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.

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

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

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Headline News

RYZ101 slows disease progression in Phase 3 ACTION-1 interim analysis for gastroenteropancreatic neuroendocrine tumours


Regeneron’s Pasatru shows no new bone lesions in adult FOP patients between weeks 56 and 84 of OPTIMA


Efzimfotase alfa misses statistical significance on primary walking endpoint but improves fatigue in adolescents and adults with hypophosphatasia in HICKORY Phase III trial


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Upcoming Webinars

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Past Webinars

Potential use of handheld Raman devices as tools for screening medicines for quality

Presented by Dr. Patrick Lukulay & Dr. Mustapha Hajjou
08th June 2015


Data as an asset – what does this mean to you?

Presented by Christos Varsakelis, Team Lead Artificial Intelligence/Machine Learning at The Janssen Pharmaceutical Companies of Johnson & Johnson and Klaus Mauch, CEO at Yokogawa Insilico Biotechnology GmbH
12th April 2022


Risk Assessment of Extractables and Leachables in Different Phases of Development.

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Ward d’Autry, Study Director E/L & Structural Elucidation, Nelson Labs Europe
22nd April 2021


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