As more therapeutic cell products are reaching the later stages of clinical trials, greater consideration is being placed on production processes that will provide commercial-scale quantities of living cell products. In particular, attention is being paid to the large-scale production of therapeutic cells,1 with downstream processing and fill-finish operations being cited as bottlenecks in current and future cell manufacturing.
Many current cell-based products are produced, frozen, stored and delivered in blood bags – technology borrowed from the blood-banking industry – owing to the available infrastructure for processing cells into bags, and for the freezing and storing of cells. While these are sufficient for small-scale processes that generate tens of product doses per lot, lot sizes of hundreds to thousands of doses will be required to supply a commercial-scale cellular product, which may preclude the use of bags.
This study evaluated the suitability of scalable final container systems in the form of stoppered vials, which are currently used for storing and distributing pharmaceutical drugs. Pharma-grade vials provide the benefits of ease-of-delivery for care givers, as well as being able to leverage existing pharmaceutical manufacturing infrastructure. Importantly, there are established standards in sizes, quality and regulatory attributes that can be drawn upon to facilitate uptake in the rapidly developing cell therapy industry.
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