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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



Headline News

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


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


Admilparant meets primary endpoint at 60 mg dose in Phase 3 ALOFT-IPF trial for idiopathic pulmonary fibrosis


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Characterization of Subvisible Particles in Protein and Viral Vaccines

Presented by Marina Kirkitadze,Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple
21st May 2019


Material Understanding for Continuous Manufacturing of Solid Dosage Forms

Presented by Dr Yifan Wang, Regulatory Research Scientist, FDA CDER and Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific
23rd August 2018


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

Presented by Kathryn McGohan, Bristol-Myers Squibb and Dr Hélène Pora and Dr James Hathcock of Pall Biotech
20th March 2018


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