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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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

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

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

Overcoming Obstacles in AAV Viral Vector Manufacturing

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Headline News

Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer


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Upcoming Webinars

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Past Webinars

Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


Commercial Cell Therapy Experience Using Mycoplasma NAT For Product Release: Five-Year Review

Presented by John Duguid, Executive Director, Research & Development at Vericel Corporation and Lori Daane, Pharma Microbiology Sr. Scientific Director at bioMérieux and Mike Brewer, Director, Global Principal Consultant, Regulatory, BioProduction at Thermo Fisher Scientific
01st November 2022


Successful Scale Up of a High Yielding Viral Vector Suspension Platform to 500 L

Presented by John Ketz, Process Development Senior Scientist, Andelyn Biosciences, Denis Kole, Director - AcceleratorSM Processes Development Services, Pall Corporation and Benben Song, Product Manager Services, Pall Corporation
12th July 2022


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