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Review
. 2022;211(3):269-281.
doi: 10.1159/000517422. Epub 2021 Aug 11.

Microphysiological Systems: Stakeholder Challenges to Adoption in Drug Development

Passley Hargrove-Grimes  1 , Lucie A Low  2 , Danilo A Tagle  2
Affiliations
Review

Microphysiological Systems: Stakeholder Challenges to Adoption in Drug Development

Passley Hargrove-Grimes et al. Cells Tissues Organs. 2022.

Abstract

Microphysiological systems (MPS) or tissue chips/organs-on-chips are novel in vitro models that emulate human physiology at the most basic functional level. In this review, we discuss various hurdles to widespread adoption of MPS technology focusing on issues from multiple stakeholder sectors, e.g., academic MPS developers, commercial suppliers of platforms, the pharmaceutical and biotechnology industries, and regulatory organizations. Broad adoption of MPS technology has thus far been limited by a gap in translation between platform developers, end-users, regulatory agencies, and the pharmaceutical industry. In this brief review, we offer a perspective on the existing barriers and how end-users may help surmount these obstacles to achieve broader adoption of MPS technology.

Keywords: Bioengineering; Drug development; Induced pluripotent stem cells; Microfluidics; Microphysiological systems.

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Conflict of interest statement

Statements

Conflict of Interest Statement

“The authors have no conflicts of interest to declare.”

Figures

Fig. 1.
Fig. 1.. Organ-on-Chip End Uses.
Organs-on-chips (MPS, Tissue Chips) have a variety of end uses, including (A) safety and toxicity testing*, (B) disease modeling of both common and rare diseases, and (C) applications for personalized medicine such as ‘you-on-a-chip’ made with patient specific stem blood or skin cells that can be reprogrammed into induced pluripotent stem cells, and further differentiated into a variety of tissue and organ constructs. *NB. the robot arm depicted in Fig 1A is typically used in high throughput screens. MPS platforms are currently employed in low-to-moderate throughput applications (Created using BioRender).
Fig. 2.
Fig. 2.. Hurdles to Adoption of Organ-on-Chip Systems Based on Stakeholder Group.
There are a variety of stakeholder groups that must communicate effectively to advance adoption of MPS technology. The hurdles to adoption of this technology vary depending on stakeholder sector. For example, developers and suppliers face hurdles such as proper cell sourcing, which cell scaffolds to use, platform fabrication and how to integrate different tissue and organ-construct platforms (section 1). The pharmaceutical industry faces different hurdles including the need to qualify MPS systems for specific contexts of use (CoU) and specific assays. The pharma industry is also interested in cross comparison of pre-clinical animal data, clinical human data, and tissue chip data (detailed in section 2). Similarly, regulatory agencies are also interested in qualifying MPS platforms for specific CoU. Regulatory bodies also require additional validation and standards development to surmount adoption hurdles (detailed in section 3). (Created using BioRender).
See this image and copyright information in PMC

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