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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


Featured Articles

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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Enabling Total Biopharma Solutions

Pall Life Sciences

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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Upcoming Webinars

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Past Webinars

From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
27th March 2019


Analytical Strategies for Comparability in Bioprocess Development

Presented by Dr Christine P. Chan, Director in Global Manufacturing Science & Technology at Sanofi
15th September 2020


The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry

Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology Center of Excellence, Technical Operations, Janssen Pharmaceuticals and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
16th March 2020


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