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...

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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Coupling single-pass TFF before loading onto a chromatography sorbent

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

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Headline News

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


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Upcoming Webinars

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Past Webinars

Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada and Dean Roberts, Director of Market and Technology Development, Bruker Applied Spectroscopy, North America
16th November 2021


Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


An Interview with Dr Günter Jagschies, of GE BioProcess teams on What are the main opportunities and challenges in the rapidly evolving Asian biopharma markets?

Presented by An Interview with Dr. Günter Jagschies, business advisor for the GE BioProcess teams
18th June 2018


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