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Organ-on-a-Chip/Tissue-on-a-Chip Engineering and Efficacy Standardization Working Group

Background

Advances in microfluidic technologies have led to innovative lab-on-a-chip, organ-on-a-chip (OoC)/tissue-on-a-chip (ToC), and other advanced in vitro three-dimensional (3D) modeling systems. These in vitro platforms have been increasingly used to study cell cultures/tissues under normal and disease states, thus helping develop drugs and theranostics. In addition to the advantages they may offer over conventional in vitro cell culture and animal experiments, these technologies have their specific properties and limitations. While many of these approaches use the same biomaterials and microfabrication techniques, and some have already become commercially available products, there are still biomaterials, cells-related and process-based risks that must be reasonably determined, addressed, and reduced to an acceptable level.

There are notable examples of microfluidic devices and on-chip products in different countries, with early adoption in various research and development level projects. The ultimate promise for many of these devices is the potential to be used as an accepted drug testing platform, which, when validated and standardized, can largely reduce animal testing and limit the problems seen in drug candidate attrition due to inadequacy of the two-dimensional (2D) cell culture models. Thus, a validated and standardized platform will, in turn, reflect on industrial advancements of biomedical products well beyond the current limits.

To achieve this potential and advance the use of microfluidics-based technologies, standardization is required, which, once in place, will also help regulatory bodies and industry to get approvals and achieve better technology penetration and acceptance in the scientific community, industry, and clinics. Stakeholders in other areas of microfluidic technologies such as flow control, interconnections, and others have already started international standardization efforts in these areas. Bringing together a working group with interdisciplinary expertise that covers a wide range of stakeholders to develop guidelines and standards for OOC is required and timely.

Mission

This working group has the mission to build up the basis for publications regarding guidelines as well as important engineering aspects of OoC/ToC, which can serve as the first step towards standardization of these systems. Mapping out as many aspects of standardization as possible will ultimately provide us with a roadmap for OoC/ToC standardization.

Current Contributors/
Stakeholders (in alphabetical order)

ATCC

Emulate

Hesperos, Inc.

FDA

Kiyatec, Inc.

Michigan State University

NIST

Synvivo

Xona Microfluidics

Working Group Coordinators

Darwin R. Reyes, Ph.D. (NIST) 

Nureddin Ashammakhi, M.D., Ph.D. (Michigan State University)

Created May 9, 2022, Updated June 8, 2022