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

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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Headline News

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines


Moderna advances Bundibugyo ebolavirus vaccine toward Phase II/III study


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Upcoming Webinars

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Past Webinars

The Importance of Accurate Chemical Characterization of Medical Devices Extractables

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christiaens, PhD, Scientific Director at Nelson Labs
16th November 2022


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


Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Justin Moretto, Life Science Product Marketing Manager at Kaiser Optical Systems, Inc
06th September 2021


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