TY - JOUR
AU - Darwin R. Reyes
AU - Mandy B. Esch
AU - Lorna Ewart
AU - Rohollah Nasiri
AU - Anna Herland
AU - Kyung Sung
AU - Monica Piergiovanni
AU - Carolina Lucchesi
AU - James T. Shoemaker
AU - Jelena Vukasinovic
AU - Hiroki Nakae
AU - James Hickman
AU - Kapil Pant
AU - Anne Taylor
AU - Niki Heinz
AU - Nureddin Ashammakhi
AB - Limitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment, and in vitro pre-clinical evaluation. This has resulted in the development of microfluidic-based cultures that may better represent organs and organ systems in vivo than conventional monolayer cell cultures. Although there is considerable interest from industry and regulatory bodies in this technology, several challenges need to be addressed for it to reach its full potential. Among those is a lack of guidelines and standards. Therefore, a multidisciplinary team of stakeholders was formed, with members from the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), European Union, academia, and industry, to provide a framework for future development of guidelines/standards governing engineering concepts of organ-on-a-chip models. The result of this work is presented here for interested parties, stakeholders, and other standards development organizations (SDOs) to foster further discussion and enhance the impact and benefits of these efforts.
BT - Lab on a Chip
DA - 2024-02-15
DO - 10.1039/D3LC00994G
LA - en
N2 - Limitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment, and in vitro pre-clinical evaluation. This has resulted in the development of microfluidic-based cultures that may better represent organs and organ systems in vivo than conventional monolayer cell cultures. Although there is considerable interest from industry and regulatory bodies in this technology, several challenges need to be addressed for it to reach its full potential. Among those is a lack of guidelines and standards. Therefore, a multidisciplinary team of stakeholders was formed, with members from the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), European Union, academia, and industry, to provide a framework for future development of guidelines/standards governing engineering concepts of organ-on-a-chip models. The result of this work is presented here for interested parties, stakeholders, and other standards development organizations (SDOs) to foster further discussion and enhance the impact and benefits of these efforts.
PY - 2024
ST - From animal testing to in vitro systems
T2 - Lab on a Chip
TI - From animal testing to in vitro systems: advancing standardization in microphysiological systems
UR - https://pubs.rsc.org/en/content/articlelanding/2024/lc/d3lc00994g
Y2 - 2024-02-23
SN - 1473-0189
ER -