RT Journal Article
T1 Evaluation of the effectiveness of a new cryopreservation system based on a two-compartment vial for the cryopreservation of cell therapy products.
A1 Rosell-Valle, Cristina
A1 Antunez, Cristina
A1 Campos, Fernando
A1 Gallot, Natalia
A1 Garcia-Arranz, Mariano
A1 Garcia-Olmo, Damian
A1 Gutierrez, Rosario
A1 Hernan, Roberto
A1 Herrera, Concha
A1 Jimenez, Rosario
A1 Leyva-Fernandez, Laura
A1 Maldonado-Sanchez, Rafael
A1 Muñoz-Fernandez, Raquel
A1 Nogueras, Sonia
A1 Ortiz, Lourdes
A1 Piudo, Inmaculada
A1 Ranchal, Isidora
A1 Rodriguez-Acosta, Antonio
A1 Segovia, Cristina
A1 Fernandez-Muñoz, Beatriz
K1 DMSO
K1 Limbo
K1 Me(2)SO
K1 Freezing
K1 Mesenchymal stromal cells
K1 Thawing
K1 Red Andaluza Para el Diseño y Traslación de Terapias Avanzadas
AB Successful cell cryopreservation and banking remain a major challenge for the manufacture of cell therapy products, particularly in relation to providing a hermetic, sterile cryovial that ensures optimal viability and stability post-thaw while minimizing exposure to toxic cryoprotective agents, typically dimethyl sulfoxide (Me2SO). In the present study, the authors evaluated the effectiveness and functionality of Limbo technology (Cellulis S.L., Santoña, Spain). This system provides a hermetic vial with two compartments (one for adding cells with the cryoprotective agent solution and the other for the diluent solution) and an automated defrosting device. Limbo technology (Cellulis S.L.) allows reduction of the final amount of Me2SO, sidestepping washing and dilution steps and favoring standardization. The study was performed in several Good Manufacturing Practice laboratories manufacturing diverse cell therapy products (human mesenchymal stromal cells, hematopoietic progenitor cells, leukapheresis products, fibroblasts and induced pluripotent stem cells). Laboratories compared Limbo technology (Cellulis S.L.) with their standard cryopreservation procedure, analyzing cell recovery, viability, phenotype and functionality. Limbo technology (Cellulis S.L.) maintained the viability and functionality of most of the cell products and preserved sterility while reducing the final concentration of Me2SO. Results showed that use of Limbo technology (Cellulis S.L.) offers an overall safe alternative for cell banking and direct infusion of cryopreserved cell products into patients.
PB Elsevier
YR 2020
FD 2020-12-16
LK http://hdl.handle.net/10668/17347
UL http://hdl.handle.net/10668/17347
LA en
NO Rosell-Valle C, Antúnez C, Campos F, Gallot N, García-Arranz M, García-Olmo D, et al. Evaluation of the effectiveness of a new cryopreservation system based on a two-compartment vial for the cryopreservation of cell therapy products. Cytotherapy. 2021 Aug;23(8):740-753
DS RISalud
RD Apr 11, 2025