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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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

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

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Headline News

Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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Upcoming Webinars

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Past Webinars

In Depth Characterization with Mass Spectrometry and Orthogonal Methods of Conformers in a Trispecific HIV Antibody

Presented by Bruno Genet, Lab head Structural Analysis MS at Sanofi
18th November 2020


Compression of film-coated pellets – key parameters for optimal tablet quality

Presented by Karl G. Wagner, Professor in Pharmaceutical Technology at the University of Bonn
04th March 2015


Orthogonal Measures of Lentiviral Particle Attributes Using DLS, NTA, and Micro Flow Cytometry

Presented by Jim Richardson, Senior Director, Analytical Development at Interius Biotherapeutics and Kevin Lance, PhD, Director of Analytics Marketing at Unchained Labs
16th February 2023


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