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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 twodimensional 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.
Human plasma and serum are increasingly used as physiologically relevant stimuli in cell culture models because they expose cells to a complex biological milieu rather than to single cytokines, lipopolysaccharide, or other simplified stimuli. This approach is particularly relevant for translational studies of inflammatory, vascular, metabolic, infectious, and post-acute disease mechanisms, where circulating factors can collectively alter cell function.
However, the same biological complexity that makes plasma treatment attractive also makes it difficult to reproduce. The plasma composition is influenced by donor characteristics, the collection tube, anticoagulant, processing time, storage, freeze-thaw history, filtration, dilution, culture medium composition, and exposure duration. In addition, the interaction between plasma and the cell culture medium can create major technical artefacts.
The purpose of this document is therefore to specify minimum requirements for using human plasma in in vitro cell models. This document is intended to support harmonized experimental planning, sample handling, treatment setup, quality control, and reporting when human plasma is used as a complex biological stimulus in cell-based studies.
The document is based on research results from EU HORIZON project POINT, and on general methodological considerations from the literature on human plasma and serum application to cell culture.
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