| Autor: |
Reyes DR; National Institute of Standards and Technology (NIST), Gaithersburg, MD, USA. darwin.reyes@nist.gov., Esch MB; National Institute of Standards and Technology (NIST), Gaithersburg, MD, USA. darwin.reyes@nist.gov., Ewart L; Emulate, Inc., Boston, Massachusetts, USA., Nasiri R; Royal Institute of Technology, Stockholm, Sweden., Herland A; Royal Institute of Technology, Stockholm, Sweden., Sung K; Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Piergiovanni M; European Commission, Joint Research Centre (JRC), Ispra, Italy., Lucchesi C; BioneXus Foundation, ATCC, Manassas, VA, USA., Shoemaker JT; Lena Biosciences, Inc., Atlanta, Georgia, USA., Vukasinovic J; Lena Biosciences, Inc., Atlanta, Georgia, USA., Nakae H; JMAC Japan bio Measurement & Analysis Consortium, Tokyo, Japan., Hickman J; Hesperos, Inc., Orlando, Florida, USA., Pant K; SynVivo, Inc., Huntsville, Alabama, USA., Taylor A; Xona Microfluidics, Inc., Research Triangle Park, North Carolina, USA., Heinz N; Altis Biosystems, Inc., Durham, North Carolina, USA., Ashammakhi N; Institute for Quantitative Health Science and Engineering, Department of Biomedical Engineering, College of Engineering, and College of Human Medicine, Michigan State University, East Lansing, MI, USA. ashammak@msu.edu. |
| Abstrakt: |
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. |
