Developments in T Cell Based Cancer Immunotherapies by Paolo A. Ascierto David F. Stroncek & Ena Wang

Author:Paolo A. Ascierto, David F. Stroncek & Ena Wang
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

Product Testing

It’s important to evaluate the cellular product at several time points during the manufacturing process. The starting material is tested to be sure that a sufficient quantity of the desired cells are present and to ensure that quantities of contaminating cells are below critical levels. The starting material is usually tested for sterility and identity. The final product should be tested for quantities of desired and contaminating cells, endotoxin level and sterility. For cultured products, in addition to sterility, mycoplasma and endotoxin testing is required. It is also desired to measure the critical biological function or potency of the final product.

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