Introduction
Many Organ-on-Chip platforms are still not robust for all cell types, are not reproducible from experiment to experiment or user to user, and should be independently qualified as fit for purpose. Furthermore, they are not always compatible with end-user lab workflows. These and other barriers must be overcome before OoC models can be adopted by the industry and accepted as animal alternatives by regulators.
The government regulations regarding Microphysiological system platforms should take into consideration the complexity of models in addition to promoting compatibility to make them more user-friendly. Regulators being involved in the process of development of Microphysiological systems is key as the end goal of the development of these models is to replace animal models and regulators have direct overview of it.
How to culture vascularized & immunocompetent 3D models in a standard Multiwell
Abstract
The authors state that “Organ-on-chip (OoC) and multi-organs-on-chip (MOoC) systems have the potential to play an important role in drug discovery, disease modeling, and personalized medicine. However, most devices developed in academic labs remain at a proof-of-concept level and do not yet offer the ease of use, manufacturability, and throughput that are needed for widespread application.
Commercially available OoC is easier to use but often lacks the level of complexity of the latest devices in academia. Furthermore, researchers who want to combine different chips into MOoC systems are limited to one supplier, since commercial systems are not compatible with each other.
Given these limitations, the implementation of standards in the design and operation of OoCs would strongly facilitate their acceptance by users. Importantly, the implementation of such standards must be carried out by many participants from both industry and academia to ensure widespread acceptance and adoption.
This means that standards must also leave room for proprietary technology development next to promoting interchangeability. An open platform with standardized interfacing and user-friendly operation can fulfill these requirements. In this Perspective article, the concept of an open platform for OoCs is defined from a technical perspective. Moreover, we discuss the importance of involving different stakeholders in the development, manufacturing, and application of such an open platform.”
References
Vollertsen AR, Vivas A, van Meer B, van den Berg A, Odijk M, van der Meer AD. Facilitating implementation of organs-on-chips by open platform technology. Biomicrofluidics. 2021 Oct 12;15(5):051301. DOI: 10.1063/5.0063428. PMID: 34659603; PMCID: PMC8514251.
FAQ
Several barriers must be overcome before Organ-on-Chip (OoC) models can be widely adopted. Many current platforms are not dependable for all cell types. Results are not always reproducible from one experiment to another or between different users. The systems also require independent qualification to show they are fit for their intended purpose. Another challenge is that platforms are not always compatible with the existing lab workflows of end-users. These issues are preventing acceptance by the industry. They also hinder acceptance by regulators as alternatives to animal models.
Devices from academic labs and commercial sources have different limitations. Most systems developed in academic labs remain at a proof-of-concept stage. They often do not provide the necessary ease of operation for general use. They also lack manufacturability and the capacity for high-volume processing needed for broad application. In contrast, commercially available Organ-on-Chip systems are generally easier to operate. These commercial options, however, frequently do not include the same degree of complexity found in the latest devices from academia.
Researchers face limitations when attempting to build multi-organs-on-chip (MOoC) systems. The main difficulty arises from a lack of compatibility between different commercial platforms. Systems from different suppliers cannot be connected to each other. This means researchers who wish to combine different chips into a multi-organ model are restricted to using components from only one supplier. This inability to interchange parts prevents the assembly of more complex models. For example, a user cannot easily combine a liver model from one company with a kidney model from another.
The introduction of an open platform could help solve current challenges. Such a platform would be based on standards for the design and operation of Organ-on-Chip systems. This standardisation would promote easier acceptance by users. An open platform with standardised interfacing and more straightforward operation is proposed. It is noted that the creation of these standards must be done by many participants. This includes groups from both industry and academia to ensure wide adoption. A balance must be struck: the standards must allow for proprietary technology to be developed while also promoting interchangeability.
