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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...

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JSR Life Sciences


Featured Articles

Changing Column Packing from an Art into a Science

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

Navigating Technology Transfer

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

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


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Upcoming Webinars

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Past Webinars

Exosome Manufacture Based on the iCELLis® Bioreactor Platform

Presented by David Haylock, CEO VivaZome Therapuetics and Roberto Ciboldi, Senior Scientist, Purification Team, Scientific & Laboratories Services Pall Corporation
11th May 2021


Points to consider when defining a microbial control strategy for individualized ATMPs

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project (individualized Neoantigen Specific Therapy)
05th April 2023


From Concept to Market – Unique approaches in Biomanufacturing

Presented by Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
18th September 2019


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