Starting Strong with Assured Supply of Quality Materials for Immune Cell Therapies
This blog post is the second in a series about accelerating the development and manufacturing of cell-based cancer therapies. In the last post, we outlined the promise and potential of immune cell therapies to treat cancer along with an overview of the central challenges that impede their broad accessibility. In this article, we take a closer look at key considerations for establishing a reliable supply chain of quality materials to ensure a robust and reproducible workflow.
As immune cell therapies advance through the development pipeline, the need for an optimal scaling strategy becomes more apparent. Much of the deliberation centers around cell expansion approaches to attain clinically relevant cell numbers and features such as automation and process control to ensure high-quality cell products. Yet there are many more decisions to be made that can to a large degree determine the ultimate success or failure of a large-scale immune cell therapy manufacturing process, such as which starting materials to use and which suppliers to partner with.
At clinical stages, cell expansion, viability, and efficacy depend on the timely arrival of high-quality GMP raw materials and reagents, and any disruption in supply can lead to variability or delays in the process and product. And while assured supply of source material has always been appreciated, disruptions due to COVID-19 highlighted how imperative it is to establish resilient and flexible supply chains from the start. Failure to mitigate disruptions can result in costly time delays and ultimately grave consequences for the patient. Therefore, when choosing starting materials, both quality and assured supply of resources must be evaluated for successful scale-up.