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Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium

Authors :
Silvia Berisa-Prado
Natalia Vázquez
Manuel Chacón
Mairobi Persinal-Medina
Sergio Alonso-Alonso
Begoña Baamonde
José F. Alfonso
Luis Fernández-Vega-Cueto
Jesús Merayo-Lloves
Álvaro Meana
Source :
Pharmaceutics, Vol 13, Iss 8, p 1282 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

Among several requirements for the manufacture of Advanced Therapy Medicinal Products (ATMP) are: following the guidelines of a pharmaceutical quality system, complying with Good Manufacturing Practice (GMP) and access to a cleanroom fulfilling strict environmental conditions (Class A work area and Class B environment). This makes ATMP expensive. Moreover, the production of many of these therapeutic products may also be unprofitable, as in most cases their use is limited to a few patients and to a single batch per manufacturing unit. To reduce costs, ATMP may be produced in a scaled-down system isolated from the external environment (isolator), allowing for placement of this facility in a Class D environment, which is much more permissive and less costly. In this work, we confirm that it is possible to manufacture bioengineered corneal epithelium inside an isolator while fulfilling all the safety assurance standards at an affordable cost for patients. This small-scale ultra-clean working environment complies with GMP guidelines and could be a solution for the high costs associated with conventional cleanroom ATMP production.

Details

Language :
English
ISSN :
19994923
Volume :
13
Issue :
8
Database :
Directory of Open Access Journals
Journal :
Pharmaceutics
Publication Type :
Academic Journal
Accession number :
edsdoj.89e21da9b7ec4661a82f3342a5d12d5c
Document Type :
article
Full Text :
https://doi.org/10.3390/pharmaceutics13081282