Abstract

Three Things Count for MPS and Organoids: Quality, Quality and Quality!

Thomas Hartung, Professor and Doerenkamp-Zbinden Chair for Evidence-based Toxicology, Director of the Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health

The promise of the novel cell culture technologies (microphysiological systems, MPS, including organ-on-chip models ad organoids) replicating organ architecture and function is counterbalanced by the demanding technologies, efforts and costs, often limiting throughput and number of replicates. With increasing desire to use them also in the regulatory context, the quality of work comes into focus. The first quality concerns the fidelity of the model in replicating (patho-)physiology and relevant responses. This is typically addressed by validation, but the complexity of models and responses requires an adaptation of the validation process. The second quality refers to the quality of performance of the work. In the regulatory context, Good Laboratory Practice (GLP) and the associated Good In Vitro Method Practice (GIVIMP) still require adaptation to MPS. Good Cell Culture Practice (GCCP), which is more geared toward defining minimum standards also applicable in non-GLP environments, is undergoing already such adaptations and with stakeholder review on the way, GCCP 2.0 is expected to be finalized later in 2021. The third quality refers to the quality of reporting. Two initiatives, i.e., the In Vitro Critical Appraisal Tool (IV-CAT) and Good In Vitro Reporting Standards (GIVReSt) are on the way. Together with organizations like the US Food and Drug Administration (FDA) defining their performance standards, these quality assurance and control initiatives pave the way for relevant, reproducible science and maximum impact of MPS technologies. The 2022 MPS World Summit aims to foster these quality initiatives also with the planned creation of an International society.