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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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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. |
format | Online Article Text |
id | pubmed-8401053 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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