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

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...

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Autores principales: Berisa-Prado, Silvia, Vázquez, Natalia, Chacón, Manuel, Persinal-Medina, Mairobi, Alonso-Alonso, Sergio, Baamonde, Begoña, Alfonso, José F., Fernández-Vega-Cueto, Luis, Merayo-Lloves, Jesús, Meana, Álvaro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401053/
https://www.ncbi.nlm.nih.gov/pubmed/34452243
http://dx.doi.org/10.3390/pharmaceutics13081282
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author Berisa-Prado, Silvia
Vázquez, Natalia
Chacón, Manuel
Persinal-Medina, Mairobi
Alonso-Alonso, Sergio
Baamonde, Begoña
Alfonso, José F.
Fernández-Vega-Cueto, Luis
Merayo-Lloves, Jesús
Meana, Álvaro
author_facet Berisa-Prado, Silvia
Vázquez, Natalia
Chacón, Manuel
Persinal-Medina, Mairobi
Alonso-Alonso, Sergio
Baamonde, Begoña
Alfonso, José F.
Fernández-Vega-Cueto, Luis
Merayo-Lloves, Jesús
Meana, Álvaro
author_sort Berisa-Prado, Silvia
collection PubMed
description 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.
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spelling pubmed-84010532021-08-29 Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium Berisa-Prado, Silvia Vázquez, Natalia Chacón, Manuel Persinal-Medina, Mairobi Alonso-Alonso, Sergio Baamonde, Begoña Alfonso, José F. Fernández-Vega-Cueto, Luis Merayo-Lloves, Jesús Meana, Álvaro Pharmaceutics Article 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. MDPI 2021-08-17 /pmc/articles/PMC8401053/ /pubmed/34452243 http://dx.doi.org/10.3390/pharmaceutics13081282 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Berisa-Prado, Silvia
Vázquez, Natalia
Chacón, Manuel
Persinal-Medina, Mairobi
Alonso-Alonso, Sergio
Baamonde, Begoña
Alfonso, José F.
Fernández-Vega-Cueto, Luis
Merayo-Lloves, Jesús
Meana, Álvaro
Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title_full Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title_fullStr Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title_full_unstemmed Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title_short Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
title_sort mini cleanroom for the manufacture of advanced therapy medicinal products (atmp): bioengineered corneal epithelium
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401053/
https://www.ncbi.nlm.nih.gov/pubmed/34452243
http://dx.doi.org/10.3390/pharmaceutics13081282
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