Evaluation of the effectiveness of a new cryopreservation system based on a two-compartment vial for the cryopreservation of cell therapy products

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, typi...

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Published in:	Cytotherapy (Oxford, England) Vol. 23; no. 8; pp. 740 - 753
Main Authors:	Rosell-Valle, Cristina, Antúnez, Cristina, Campos, Fernando, Gallot, Natalia, García-Arranz, Mariano, García-Olmo, Damian, Gutierrez, Rosario, Hernán, Roberto, Herrera, Concha, Jiménez, Rosario, Leyva-Fernández, Laura, Maldonado-Sanchez, Rafael, Muñoz-Fernández, Raquel, Nogueras, Sonia, Ortiz, Lourdes, Piudo, Inmaculada, Ranchal, Isidora, Rodríguez-Acosta, Antonio, Segovia, Cristina, Fernández-Muñoz, Beatriz
Format:	Journal Article
Language:	English
Published:	England Elsevier Inc 01-08-2021
Subjects:	DMSO freezing Limbo Me2SO mesenchymal stromal cells thawing thawing freezing DMSO Limbo Me2SO mesenchymal stromal cells MeSO
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Abstract	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. [Display omitted]
AbstractList	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. [Display omitted] 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 (Me SO). 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 Me SO, 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 Me SO. 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.
Author	Campos, Fernando Herrera, Concha Gallot, Natalia Maldonado-Sanchez, Rafael Leyva-Fernández, Laura Rosell-Valle, Cristina Antúnez, Cristina Hernán, Roberto Jiménez, Rosario Nogueras, Sonia Muñoz-Fernández, Raquel Gutierrez, Rosario Ranchal, Isidora García-Olmo, Damian Piudo, Inmaculada García-Arranz, Mariano Ortiz, Lourdes Fernández-Muñoz, Beatriz Rodríguez-Acosta, Antonio Segovia, Cristina
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Copyright	2020 International Society for Cell & Gene Therapy Copyright © 2020 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.
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Keywords	thawing freezing DMSO Limbo Me2SO mesenchymal stromal cells MeSO
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Title	Evaluation of the effectiveness of a new cryopreservation system based on a two-compartment vial for the cryopreservation of cell therapy products
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