ISO/NP TS 26899

Biotechnology — In vitro cell culture examinations — Requirements for the application of human plasma to cell models

Апстракт

This document specifies requirements and gives recommendations for the receipt, documentation, preparation, dilution, application, quality control and reporting of human plasma used as a stimulus in in vitro cell culture models.
This document is applicable to laboratories, researchers, biobanks, clinical collaborators, industry stakeholders, examination developers, and in vitro model developers who apply human plasma to two-dimensional or three-dimensional cell models for mechanistic, translational, medical, pharmacological, or examination-development purposes.
This document is particularly applicable to cell models in which plasma is used to assess cellular stress, inflammatory activation, bioenergetics, metabolic responses, barrier function, morphology, viability, gene expression or other downstream phenotypes.
This document is not applicable to the clinical transfusion of plasma, diagnostic decision-making from patient plasma, manufacture of plasma-derived medicinal products, or analytical measurement of plasma analytes where the plasma is not applied to living cell models.