Some ATMPs contain living cells. These cell-based therapies may be cryopreserved to extend their shelf life, requiring carefully controlled thawing prior to administration. Failure to thaw the product correctly may impair the integrity of the cells (viability and/or function) and the product may be rendered unfit for purpose. This document describes and example procedure for thawing cryopreserved ATMPs using a water bath.
Thawing procedure for cryopreserved ATMPs using a water bath
Kamilah Lakhani-Powell2023-02-22T15:37:13+00:0014th October 2021|