Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium
| Autor: | Jesus Merayo-Lloves, Begoña Baamonde, Sergio Alonso-Alonso, Mairobi Persinal-Medina, Silvia Berisa-Prado, Natalia Vázquez, Alvaro Meana, Manuel Chacon, José F. Alfonso, Luis Fernández-Vega-Cueto |
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| Rok vydání: | 2021 |
| Předmět: |
Computer science
Pharmaceutical Science advanced therapy medicinal products Manufacturing engineering Article RS1-441 chemistry.chemical_compound ophthalmology Pharmacy and materia medica Quality management system hospital pharmacy chemistry Cleanroom Safety assurance Good manufacturing practice ATMP Working environment |
| Zdroj: | Pharmaceutics Pharmaceutics, Vol 13, Iss 1282, p 1282 (2021) WOS:000690169300001 RUO. Repositorio Institucional de la Universidad de Oviedo instname Volume 13 Issue 8 |
| ISSN: | 1999-4923 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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