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

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

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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

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Headline News

CHMP backs extended Libtayo dosing schedule across approved EU cancer indications


TAK-881 matches HYQVIA exposure while reducing infusion volume in Phase II/III PID study


Takeda launches ORZEYFUL in Japan and China for narcolepsy type 1


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Upcoming Webinars

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Past Webinars

Novel Technologies That Aid the Detection and Differentiation of Proteinaceous Impurities in Biologic Drug Substances and Drug Product

Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
30th November 2020


New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany
09th April 2019


The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
02nd September 2020


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