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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

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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

Monica Cardona and Ian Johnson Pall Life Sciences

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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

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Headline News

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


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


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


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Upcoming Webinars

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Past Webinars

Designer Sterile Filtration in Aseptic Processing Using Single Use Technology

Presented by Alan Kelly, Project Engineer at Sanofi and Terri Love, Senior BioManufacturing at Merck
10th November 2020


Real Time Monitoring of Bioprocess and Beyond – A Process Analytical Perspective

Presented by Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb and Julia Ding, Head, Global Process Analytical Development at Bristol Myers Squibb and Eric Carlson, Ph.D., President & CEO, Protein Metrics Inc.
16th November 2020


Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody Drug Conjugates

Presented by Arnaud Delobel, PhD, R&D Director at Quality Assistance sa
12th September 2017


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