دورية أكاديمية
GMP-Compliant Production of Autologous Adipose-Derived Stromal Cells in the NANT 001 Closed Automated Bioreactor.
| العنوان: | GMP-Compliant Production of Autologous Adipose-Derived Stromal Cells in the NANT 001 Closed Automated Bioreactor. |
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| المؤلفون: | Cattaruzzi, Giacomo, Vitrani, Francesco, Mazzarol, Flavia, Mauro, Prisca, Sfiligoj, Antonio, Curcio, Francesco, Jones, Deirdre M, McInerney, Veronica, Krawczyk, Janusz, Kelly, Jack, Finnerty, Andrew, McDonagh, Katya, Duggan, Matthew, Connolly, Lauren, Shaw, Georgina, Murphy, Mary, Barry, Frank, Fitzgerald, Joan, Duffy, Niamh, Paulitti, Alice, McCabe, Una |
| المصدر: | Frontiers in bioengineering and biotechnology ; 10 ; 834267 ; Switzerland |
| سنة النشر: | 2022 |
| المجموعة: | Lenus - Irish Health Publications Archive (HSE - Health Service Executive) |
| مصطلحات موضوعية: | automation, mesenchymal stromal cells, GMP—good manufacturing practice, autologous, bioreactor |
| الوصف: | In recent years mesenchymal stromal cells (MSCs) have received a great deal of interest for the treatment of major diseases, but clinical translation and market authorization have been slow. This has been due in part to a lack of standardization in cell manufacturing protocols, as well as a lack of biologically meaningful cell characterization tools and release assays. Cell production strategies to date have involved complex manual processing in an open environment which is costly, inefficient and poses risks of contamination. The NANT 001 bioreactor has been developed for the automated production of small to medium cell batches for autologous use. This is a closed, benchtop system which automatically performs several processes including cell seeding, media change, real-time monitoring of temperature, pH, cell confluence and cell detachment. Here we describe a validation of the bioreactor in an environment compliant with current good manufacturing practice (cGMP) to confirm its utility in replacing standardized manual processing. Stromal vascular fraction (SVF) was isolated from lipoaspirate material obtained from healthy donors. SVF cells were seeded in the bioreactor. Cell processing was performed automatically and cell harvesting was triggered by computerized analysis of images captured by a travelling microscope positioned beneath the cell culture flask. For comparison, the same protocol was performed in parallel using manual methods. Critical quality attributes (CQA) assessed for cells from each process included cell yield, viability, surface immunophenotype, differentiation propensity, microbial sterility and endotoxin contamination. Cell yields from the bioreactor cultures were comparable in the manual and automated cultures and viability was >90% for both. Expression of surface markers were consistent with standards for adipose-derived stromal cell (ASC) phenotype. ASCs expanded in both automated and manual processes were capable of adipogenic and osteogenic differentiation. Supernatants from all ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2296-4185 |
| العلاقة: | http://hdl.handle.net/10147/635967Test; Frontiers in bioengineering and biotechnology; PMC8959900 |
| DOI: | 10.3389/fbioe.2022.834267 |
| الإتاحة: | https://doi.org/10.3389/fbioe.2022.834267Test http://hdl.handle.net/10147/635967Test |
| حقوق: | Copyright © 2022 Fitzgerald, Duffy, Cattaruzzi, Vitrani, Paulitti, Mazzarol, Mauro, Sfiligoj, Curcio, Jones, McInerney, Krawczyk, Kelly, Finnerty, McDonagh, McCabe, Duggan, Connolly, Shaw, Murphy and Barry. |
| رقم الانضمام: | edsbas.F5270855 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 22964185 |
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| DOI: | 10.3389/fbioe.2022.834267 |