Fitting product to process: raw materials customization for cell therapy manufacturing success

Abstract

<!--StartFragment-->Cell therapy manufacturing involves highly complex processes, with large numbers of inputs, and therefore a high amount of associated risk. A robust supply of high quality raw and ancillary materials is crucial to successful manufacture of cell therapy products – but selecting the best supplier, and the right product, can pose a challenge. Raw material customization may require more up-front investment from manufacturers, but even relatively small modifications to packaging and fill sizing of off-the-shelf materials can provide cost-effective products that better fit process requirements, and help to de-risk manufacturing. Identifying risks up-front and customizing products where required can save time, money, and ultimately speed up commercialization of therapies.<!--EndFragment-->