Defining a regulatory strategy for ATMP/aerosol delivery device combinations in the treatment of respiratory disease

Niamh Woods, Ronan Macloughlin

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摘要

© 2020 by the authors. Licensee MDPI, Basel, Switzerland. Advanced Therapeutic Medicinal Products (ATMP) are a heterogenous group of investi-gational medicinal products at the forefront of innovative therapies with direct applicability in respiratory diseases. ATMPs include, but are not limited to, stem cells, their secretome, or extracellular vesicles, and each have shown some potential when delivered topically within the lung. This review focuses on that subset of ATMPs. One key mode of delivery that has enabling potential in ATMP validation is aerosol-mediated delivery. The selection of the most appropriate aerosol generator technology is influenced by several key factors, including formulation, patient type, patient inter-vention, and healthcare economics. The aerosol-mediated delivery of ATMPs has shown promise for the treatment of both chronic and acute respiratory disease in pre-clinical and clinical trials; however, in order for these ATMP device combinations to translate from the bench through to com-mercialization, they must meet the requirements set out by the various global regulatory bodies. In this review, we detail the potential for ATMP utility in the lungs and propose the nebulization of ATMPs as a viable route of administration in certain circumstances. Further, we provide insight to the current regulatory guidance for nascent ATMP device combination product development within the EU and US.
源语言英语
期刊Pharmaceutics
12
10
DOI
已出版 - 1 十月 2020

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