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Progress in developing microphysiological systems for biological product assessment.

Mona Mansouri1, Johnny Lam1, Kyung E Sung1

  • 1Cellular and Tissue Therapies Branch, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. kyung.sung@fda.hhs.gov.

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Summary
This summary is machine-generated.

Microphysiological systems (MPS) offer new ways to test medical products, especially biological therapies like cell and gene treatments. This review explores MPS advancements and challenges for broader use in product development.

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Area of Science:

  • Biomedical Engineering
  • Drug Discovery and Development
  • Regenerative Medicine

Background:

  • Microphysiological systems (MPS), or miniaturized physiological environments, mimic organ-level functions for research.
  • MPS complement traditional methods, aiding medical product progression from preclinical to market stages.
  • Current MPS applications predominantly focus on drug discovery, with limited use in biological product assessment.

Purpose of the Study:

  • To review technical advancements in MPS for evaluating biological products.
  • To address the gap in research concerning MPS for cellular and gene therapies.
  • To discuss challenges and considerations for integrating MPS into mainstream product testing.

Main Methods:

  • Literature review of recent technical advancements in MPS.
  • Analysis of MPS applications in biological product assessment.
  • Discussion of challenges and future directions for MPS translation.

Main Results:

  • MPS technology has advanced, showing potential for assessing biological products.
  • There is a need for more research and development in using MPS for cell and gene therapies.
  • Successful translation requires addressing technical, regulatory, and validation challenges.

Conclusions:

  • MPS hold significant promise for evaluating biological products, complementing traditional methods.
  • Further research and development are crucial to overcome barriers to MPS adoption in this field.
  • Strategic considerations are necessary for the widespread implementation of MPS in product testing and development.