White Paper: Advanced Therapies Guide

A Supply Chain Readiness Guide for cell therapies, gene therapies, and personalized cancer vaccines

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Advanced therapies require advanced supply chain management in cell therapy, gene therapy, and personalized cancer vaccines. This guide reflects decades of collective expertise and is designed to help lead your team through this complex planning and implementation process in four stages. 

Overview

This paper, written by industry experts, discusses the questions and considerations your team should address at each stage of the supply chain, and provides useful references and checklists to help make sure that nothing gets overlooked. From laying the groundwork for a strong strategy to building an operational ecosystem to fine-tuning your quality risk management program, this guide will support your team’s internal planning and your discussions with your supply chain partners, including Vineti.

  • Moving a large-molecule biologic out of the lab and into human trials requires a solid supply chain strategy. This Guide outlines how to build that strategy, and includes important definitions and checklists.
  • The ecosystem that your product will operate in is diverse and distributed, and you need to provide critical air-traffic control. Effective collaboration among all your supply chain participants will become a primary success factor, both in early-phase development and as the treatment volume scales.
  • Your drug product processes should provide streamlined communications and operations across all the many participants in your ecosystem.
  • The large number of supply chain components outside the manufacturing facility, and essential role of the patient and health care provider, requires a unique, collaborative approach to Quality Risk Management.
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