Raw & starting materials quality, sourcing and management 2022

Cell & gene therapy orchestration: supply chain management in real-time

Cell & Gene Therapy Insights 2022; 8(10), 1303–1314

DOI: 10.18609/cgti.2022.191

Published: 9 November 2022
Innovator Insight
Andreas Göbel, Dr Camila Mendes

With more Cell & Gene Therapies (CGT) entering the market, many pharma companies are currently looking into their supply chains and adapting them for the complexities and requirements that come with these novel therapies. Many startup biotech companies are doing the same thing, but with the advantage of being able to start with a greenfield project. The complex, highly collaborative supply chains of CGT require control and visibility to fulfill the very high requirements for safety, resilience, and speed that come with the underlying drug products. A very high degree of process complexity and the involvement of many different contributors, each with numerous intermediates and handovers, combine to ensure that it is almost impossible to manage more than 50 patients per year with simple tools such as Excel spreadsheets and web portals. There is a ‘magic tool’ that can provide the necessary support here – one that has been talked about for several years now: the Cell & Gene Therapy Orchestration Platform (Orchestration Platform). Biotech companies may require Orchestration Platform features that support regulatory requirements, such as chain of identity and custody, logistics management, and general collaboration. But as they move with their assets through preclinical, clinical, and eventually, commercial, it becomes clear that each of these different phases come with added requirements for the Orchestration Platform. Step by step, they will require features on different levels (workflow and integration, manufacturing, operations, tactical and strategic), depending on the product lifecycle and organizational state. In this article, we will detail all levels of a complete end-to-end supply chain management approach for personalized therapies. We will also highlight critical features of and key considerations for an Orchestration Platform and describe the phase in the product lifecycle in which each single level begins to generate its full value.