White Paper: Advanced Therapies Guide

Quality Management System readiness guide for cell therapies, gene therapies, and cancer vaccines 

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Advanced therapy supply chains have unique challenges and complexities—and risks—that require robust Quality Management Systems (QMS) to help ensure patient safety and product success. This guide explains how to build on basic Quality and risk-management principles, and includes important information on critical risks, vendor management, and Quality metrics specific to advanced therapies.


This guide will lay the foundation your team needs to understand how to utilize proven QMS principles to de-risk the complex advanced therapy supply chain. By building on these solid foundations, challenges can be more successfully managed and risks will be reduced. Good quality and compliance not only help provide patient safety, but are also good business. Additionally, this guide provides the following takeaways:

  • Six areas of the QMS where efforts can be targeted to significantly reduce supply chain risk.
  • A proven Quality Risk Management (QRM) process to enable identification of the critical supply chain risks and helps identify where to deploy limited resources for the biggest impact.
  • Partner management and metrics resources which provide actionable information that can be implemented immediately.

These approaches are effective, and have been developed and used by cell and gene therapy experts to support the consistent delivery of high-quality advanced therapy drug products.

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