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Author Spotlight: Developing a Unique Modular Microphysiological System to Mimic Human Barrier Tissue
06:20

Author Spotlight: Developing a Unique Modular Microphysiological System to Mimic Human Barrier Tissue

Published on: February 16, 2024

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A path forward advancing microphysiological systems.

Thomas Hartung1,2, Lena Smirnova1

  • 1Center for Alternatives to Animal Testing, Bloomberg School of Public Health and Whiting School of Engineering, Doerenkamp-Zbinden-Chair for Evidence-based Toxicology, Johns Hopkins University, Baltimore, MD, USA.

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PubMed
Summary
This summary is machine-generated.

Microphysiological systems (MPS) offer human-relevant in vitro models for drug development. Addressing standardization, validation, and regulatory challenges is crucial for their widespread adoption and to reduce animal testing.

Keywords:
drug developmentorgan-on-chipregulatory acceptancestandardization challengesvalidation frameworks

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Area of Science:

  • Biotechnology and Bioengineering
  • Toxicology and Pharmacology
  • Regenerative Medicine

Background:

  • Microphysiological systems (MPS), including organ-on-chip and organoid models, are advanced in vitro tools for human-relevant biological modeling.
  • These technologies engineer organ architecture and function, promising to revolutionize drug development, reduce animal testing, and enable personalized medicine.

Purpose of the Study:

  • To identify and analyze key obstacles hindering the adoption and implementation of MPS.
  • To propose actionable solutions for accelerating the development and acceptance of MPS technologies.

Main Methods:

  • Review of current challenges in MPS terminology, protocols, validation, and regulatory pathways.
  • Analysis of international initiatives and contributions, such as those from the Center for Alternatives to Animal Testing (CAAT).
  • Examination of proposed solutions including global standardization, enhanced validation frameworks, and improved data sharing.

Main Results:

  • Key challenges identified include lack of standardization, complex validation requirements, regulatory uncertainties, and data sharing barriers.
  • International efforts and collaborative initiatives are vital for progress.
  • Proposed solutions focus on global standards, specialized validation centers, pre-competitive consortia, and clear regulatory guidance.

Conclusions:

  • Overcoming challenges in standardization, validation, regulation, and data management is essential for realizing the full potential of MPS.
  • Coordinated efforts among academia, industry, and regulatory bodies are necessary for the successful integration of MPS into research and development.
  • Future priorities include addressing technical complexities, engineering hurdles, economic accessibility, and integration with emerging technologies.