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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


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


Olomorasib shows durable first-line activity in KRAS G12C-mutant lung cancer


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Upcoming Webinars

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Past Webinars

Advances and Challenges in Vaccine Development and Manufacture

Presented by Tony D'Amore, Vice Preseident, Product Research & Development at Sanofi Pasteur
02nd November 2018


Controlling variability to increase accuracy in the BET Assay

Presented by Karen McCullough, Principal consultant at MMI Associates and Alan Baines, Head of Strategic Projects for Lonza Pharma, Bioscience Solutions
05th June 2013


Raman Spectral Library for Counterfeit Detection

Presented by Dr. Jason Rodriguez, FDA Division of Pharmaceutical Analysis (DPA) and Dr. Katherine A. Bakeev, Director of Analytical Services and Support for B&W Tek
18th March 2015


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