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

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

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  

Overcoming Obstacles in AAV Viral Vector Manufacturing

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Headline News

Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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


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Upcoming Webinars

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Past Webinars

Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Dr. Magali Roche, Sales Manager, PathoQuest, Biologics Genomic Service
16th October 2020


ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022


The Business Benefits of PAT in Continuous Drug Product Manufacturing

Presented by Steve Hammond, Independent Consultant at Steve Hammond Consulting
22nd September 2021


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