Progress in developing microphysiological systems for biological product assessment
Microphysiological systems (MPS), also known as miniaturized physiological environments, have been engineered to create and study functional tissue units capable of replicating organ-level responses in specific contexts. The MPS has the potential to provide insights about the safety, characterizatio...
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| Published in | Lab on a chip Vol. 24; no. 5; pp. 1293 - 136 |
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| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Royal Society of Chemistry
27.02.2024
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| Subjects | |
| Online Access | Get full text |
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| Summary: | Microphysiological systems (MPS), also known as miniaturized physiological environments, have been engineered to create and study functional tissue units capable of replicating organ-level responses in specific contexts. The MPS has the potential to provide insights about the safety, characterization, and effectiveness of medical products that are different and complementary to insights gained from traditional testing systems, which can help facilitate the transition of potential medical products from preclinical phases to clinical trials, and eventually to market. While many MPS are versatile and can be used in various applications, most of the current applications have primarily focused on drug discovery and testing. Yet, there is a limited amount of research available that demonstrates the use of MPS in assessing biological products such as cellular and gene therapies. This review paper aims to address this gap by discussing recent technical advancements in MPS and their potential for assessing biological products. We further discuss the challenges and considerations involved in successful translation of MPS into mainstream product testing.
This review delves into microphysiological systems, miniature physiological environments used to evaluate biological products, reducing the need for animal experimentation. We consider their benefits as well as persistent challenges in material selection/fabrication and reproducibility. |
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| Bibliography: | Kyung Sung is the Chief of the Cellular and Tissue Therapies Branch in the Office of Therapeutic Products in the Center for Biologics Evaluation and Research, US Food and Drug Administration. She is responsible for overseeing both the regulatory science research programs and the regulatory review process for cell and tissue therapeutic products and medical devices. The research team focuses on studying the impact of interactions between living cells and biomaterials on product quality. They achieve this by developing innovative quantitative assays using a range of biomedical engineering tools. The main objective is to gain a comprehensive understanding of how these interactions impact the production and characterization of cellular products used in regenerative medicine. She obtained her Ph.D. in Chemical Engineering from the University of Michigan, Ann Arbor, and subsequently finished her postdoctoral training at the University of Wisconsin, Madison. Prior to joining the FDA in 2015, she gained experience as a patent examiner in Biotechnology at the US Patent and Trademark Office. Mona Mansouri is a postdoctoral researcher in the Office of Therapeutic Products in the Center for Biologics Evaluation and Research at FDA, where she studies the microenvironment's impact on cellular function. Specifically, her work focuses on understanding how an inflamed microenvironment influences the differentiation capacity of mesenchymal stem cells for treating cartilage defects. Additionally, she investigates the impact of matrix stiffness on the effectiveness of natural killer cells against tumors, revealing therapeutic potential for cancer treatment. Mona holds a Ph.D. in Chemical and Biomolecular Engineering from the University of Akron, where she explored replicating organ-level responses by manipulating the cell microenvironment with biomaterials and fluidic devices. orthopedic tissue repair. in vivo Johnny Lam is a biomedical engineer in the Office of Therapeutic Products in the Center for Biologics Evaluation and Research at FDA, where he performs both lead product review and research activities. Johnny's main research interests involve studying complex cell-based therapies and how their product quality attributes relate to functionally relevant bioactivities. His research focuses on the development and adaptation of wide-ranging microphysiological systems as platforms to evaluate various functional outcomes of various cell types toward improving the quality and potency of manufactured cell-based products. Johnny received his Ph.D. in Bioengineering in 2015 at Rice University, where he developed and evaluated injectable multi-layered hydrogel composites for cell and controlled growth factor delivery for ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1 |
| ISSN: | 1473-0197 1473-0189 |
| DOI: | 10.1039/d3lc00876b |