Gereka Ainitze, Urtaza Uzuri, Larreategi Pablo, Prosper Felipe, Andreu Enrique José, Zaldua Ane Miren
Health Specialization, Leartiker S. Coop., 48270 Markina-Xemein, Spain.
Cell Therapy Area, Clinica Universidad de Navarra, 31008 Pamplona, Spain.
Bioengineering (Basel). 2024 Aug 2;11(8):785. doi: 10.3390/bioengineering11080785.
A novel, user-friendly bioreactor for the cultivation of cellularised membranes for tissue engineering has been successfully designed, manufactured, and validated. This bioreactor features a culture vessel and a cover, the latter equipped with one or more sidewalls to ensure airtightness in two distinct zones, thereby maintaining sterile conditions. The cover, designed to integrate seamlessly with the culture vessel, includes several ports compatible with commercial connectors. This design allows the introduction of cells and culture medium without requiring the opening of the cover, thus preserving sterility. Additionally, the cover is equipped with flanges that effectively press the membrane against the bottom surface of the culture vessel, preventing it from shrinking or shifting. This ensures that cells can properly adhere to the membrane and proliferate. Manufactured under Good Manufacturing Practice (GMP) conditions, the bioreactor supports cultivation in optimal aseptic environments, thereby preventing external contamination. This feature is critical for the safe transportation of cultivated tissue to clinical settings. Validation tests have confirmed the bioreactor's excellent performance, endorsing its suitability for intended applications in tissue engineering.
一种用于组织工程的新型、用户友好型生物反应器已成功设计、制造并验证，用于培养细胞化膜。该生物反应器具有一个培养容器和一个盖子，后者配备有一个或多个侧壁，以确保在两个不同区域的气密性，从而维持无菌条件。盖子设计为与培养容器无缝集成，包括几个与商业连接器兼容的端口。这种设计允许在不打开盖子的情况下引入细胞和培养基，从而保持无菌状态。此外，盖子配备有法兰，可有效地将膜压在培养容器的底面上，防止其收缩或移位。这确保细胞能够正确地附着在膜上并增殖。该生物反应器在良好生产规范（GMP）条件下制造，支持在最佳无菌环境中培养，从而防止外部污染。这一特性对于将培养组织安全运输到临床环境至关重要。验证测试已证实该生物反应器的卓越性能，认可其适用于组织工程中的预期应用。
