Example for process validation in biobanking: Fit for purpose testing of a cryopreservation method without isopentane.

ABSTRACT: Background: The freezing process of tissue samples is crucial for the preservation of morphological and molecular features. Several biobanking guidelines describe freezing techniques for optimal outcomes. As the Vetbiobank standard freezing protocol does not comply with those recommendations in detail, a process validation was performed to demonstrate that samples are suitable for downstream applications. Here we give a formal example of a process validation in the biobanking setting, as required by the biobanking guideline ISO 20387 (2018). Methods: Three different freezing protocols, freezing in liquid nitrogen, freezing via isopentane precooled on dry ice and freezing via liquid nitrogen vapor, were assessed based on morphological integrity of mouse liver and

SUBMITTER: Wieser M 

PROVIDER: S-EPMC9562646 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature