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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

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

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

James Barry, Director of Marketing, Americas, Pall Biotech

Overcoming Obstacles in AAV Viral Vector Manufacturing

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


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Upcoming Webinars

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Past Webinars

A Versatile Solution for Host Cell Proteins (HCPs) and Aggregates Removal for mAbs Purification

Presented by Catherine Allioux & Caine Leong, Ph.D.
08th June 2017


Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech
16th March 2021


Integrity Assurance for Single-Use Systems: End-User Perspective

Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK vaccines and Patrick Evrard, Senior Principal Engineer, Single-Use Technologies in Technical Communication and Regulatory Strategy, Pall Corporation
06th October 2021


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