0
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Evaluation of a flow cytometry-based method for determination of T-lymphocyte subtypes for quality assessment of cell therapy products

, , &
Received 27 Mar 2024, Accepted 05 Jul 2024, Published online: 14 Jul 2024

References

  • Lin H, Cheng J, Mu W, et al. Advances in universal CAR-T cell therapy. Front Immunol. 2021;12:744823. doi: 10.3389/fimmu.2021.744823.
  • Delgado J, Roddie C, Schmitt M. Point-of-care production of CAR-T cells. In: Kröger N, Gribben J, Chabannon C, Yakoub-Agha I, Einsele H, editors. The EBMT/EHA CAR-T cell handbook. European Society for Blood and Marrow Transplantation and European Hematology Association. Cham, Switzerland: Springer Nature Switzerland AG; 2022. pp. 45–49.
  • Demaret J, Varlet P, Trauet J, et al. Monitoring CAR T-cells using flow cytometry. Cytometry B Clin Cytom. 2021;100(2):218–224. doi: 10.1002/cyto.b.21941.
  • Mukherjee S, Reddy O, Panch S, et al. Establishment of a cell processing laboratory to support hematopoietic stem cell transplantation and chimeric antigen receptor (CAR)-T cell therapy. Transfus Apher Sci. 2021;60(1):103066. doi: 10.1016/j.transci.2021.103066.
  • Haussmann K, Streitz M, Takvorian A, et al. Widely applicable, extended flow cytometric stem cell enumeration panel for quality control of advanced cellular products. Sci Rep. 2022;12(1):17995. doi: 10.1038/s41598-022-22339-1.
  • Mfarrej B, Gaude J, Couquiaud J, et al. Validation of a flow cytometry-based method to quantify viable lymphocyte subtypes in fresh and cryopreserved hematopoietic cellular products. Cytotherapy. 2021;23(1):77–87. doi: 10.1016/j.jcyt.2020.06.005.
  • Berger SC, Fehse B, Rubio MT. Immune monitoring. In: Kröger N, Gribben J, Chabannon C, Yakoub-Agha I, Einsele H, editors. The EBMT/EHA CAR-T cell handbook. European Society for Blood and Marrow Transplantation and European Hematology Association. Cham, Switzerland: Springer Nature Switzerland AG; 2022. pp. 77–181.
  • International Organization for Standardization (ISO). EN ISO 15189 - Medical laboratories - Requirements for quality and competence, 3th edn. Geneva, Switzerland: ISO; 2022.
  • Davis BH, Dasgupta A, Kussick S, et al. ICSH/ICCS Working Group. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues. Cytometry B Clin Cytom. 2013;84(5):286–290.
  • Tanqri S, Vall H, Kaplan D, Group IIW., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part III—analytical issues. Cytometry B Clin Cytom. 2013;84(5):291–308.
  • Barnett D, Louzao R, Gambell P, Group IIW., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part IV—postanalytic considerations. Cytometry B Clin Cytom. 2013;84(5):309–314. doi: 10.1002/cyto.b.21107.
  • Wood B, Jevremovic D, e Mc B, Group IIW., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part V—assay performance criteria. Cytometry B Clin Cytom. 2013;84(5):315–323. doi: 10.1002/cyto.b.21108.
  • der Strate BV, Longdin R, Geerlings M, et al. Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum. Bioanalysis. 2017;9(16):1253–1264. doi: 10.4155/bio-2017-0093.
  • Clinical and Laboratory Standards Institute (CLSI). User Verification of Precision and Estimation of Bias; Approved Guideline (3rd edn, EP15-A3). Wayne, PA: CLSI; 2014.
  • Rimac V, Bojanić I, Gojčeta K, et al. Evaluation of the BD Stem Cell Enumeration Kit on the BD FACSCanto II flow cytometer using BD Facscanto clinical and BD Facsdiva software. Int J Lab Hematol. 2021;43(1):61–67. doi: 10.1111/ijlh.13315.
  • Omana-Zapata I, Mutschmann C, Schmitz J, et al. Accurate and reproducible enumeration of T-, B-, and NK lymphocytes using the BD FACSLyric 10-color system: a multisite clinical evaluation. PLoS One. 2019;14(1):e0211207. doi: 10.1371/journal.pone.0211207.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.