Product release testing criteria and results of the final NK cell products.
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The table shows an overview of product release tests and product specifications for the ex-vivo generated NK cells using a closed cell culture process. The table summarized the facts needed to provide a certificate of analysis to release an UCB-NK cell therapy product for a patient. n.a. = not analyzed in validation runs but these parameters will be scored for the clinical production and the certificate of analysis. n.d.: not detected; the test do not show any positive events. yes = the results of the test fulfill the specification relevant for the certificate of analysis.
创建时间:
2011-06-16



