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Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation
Cytokine-induced killer (CIK) cells are advanced therapy medicinal products, so their production and freezing process has to be validated before their clinical use, to verify their stability as a drug formulation according to the good manufacturing practice (GMP) guidelines. We designed a stability...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281026/ https://www.ncbi.nlm.nih.gov/pubmed/32408620 http://dx.doi.org/10.3390/ph13050093 |
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author | Mareschi, Katia Adamini, Aloe Castiglia, Sara Rustichelli, Deborah Castello, Laura Mandese, Alessandra Leone, Marco Pinnetta, Giuseppe Mesiano, Giulia Ferrero, Ivana Fagioli, Franca |
author_facet | Mareschi, Katia Adamini, Aloe Castiglia, Sara Rustichelli, Deborah Castello, Laura Mandese, Alessandra Leone, Marco Pinnetta, Giuseppe Mesiano, Giulia Ferrero, Ivana Fagioli, Franca |
author_sort | Mareschi, Katia |
collection | PubMed |
description | Cytokine-induced killer (CIK) cells are advanced therapy medicinal products, so their production and freezing process has to be validated before their clinical use, to verify their stability as a drug formulation according to the good manufacturing practice (GMP) guidelines. We designed a stability program for our GMP-manufactured CIK cells, evaluating the viability, identity and potency of cryopreserved CIK cells at varying time periods from freezing, and compared them with fresh CIK cells. We evaluated the effects of the cryopreservation method, transportation, and the length of time of different process phases (pre-freezing, freezing and post-thawing) on the stability of CIK cells. This included a worst case for each stage. The expanded CIK cells were viable for up to 30 min from the addition of the freezing solution, when transported on dry ice within 48 h once frozen, within 60 min from thawing and from 12 months of freezing while preserving their cytotoxic effects. The reference samples, cryopreserved simultaneously in tubes and following the same method, were considered representative of the batch and useful in the case of further analysis. Data obtained from this drug stability program can inform the accurate use of CIK cells in clinical settings. |
format | Online Article Text |
id | pubmed-7281026 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-72810262020-06-15 Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation Mareschi, Katia Adamini, Aloe Castiglia, Sara Rustichelli, Deborah Castello, Laura Mandese, Alessandra Leone, Marco Pinnetta, Giuseppe Mesiano, Giulia Ferrero, Ivana Fagioli, Franca Pharmaceuticals (Basel) Article Cytokine-induced killer (CIK) cells are advanced therapy medicinal products, so their production and freezing process has to be validated before their clinical use, to verify their stability as a drug formulation according to the good manufacturing practice (GMP) guidelines. We designed a stability program for our GMP-manufactured CIK cells, evaluating the viability, identity and potency of cryopreserved CIK cells at varying time periods from freezing, and compared them with fresh CIK cells. We evaluated the effects of the cryopreservation method, transportation, and the length of time of different process phases (pre-freezing, freezing and post-thawing) on the stability of CIK cells. This included a worst case for each stage. The expanded CIK cells were viable for up to 30 min from the addition of the freezing solution, when transported on dry ice within 48 h once frozen, within 60 min from thawing and from 12 months of freezing while preserving their cytotoxic effects. The reference samples, cryopreserved simultaneously in tubes and following the same method, were considered representative of the batch and useful in the case of further analysis. Data obtained from this drug stability program can inform the accurate use of CIK cells in clinical settings. MDPI 2020-05-12 /pmc/articles/PMC7281026/ /pubmed/32408620 http://dx.doi.org/10.3390/ph13050093 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Mareschi, Katia Adamini, Aloe Castiglia, Sara Rustichelli, Deborah Castello, Laura Mandese, Alessandra Leone, Marco Pinnetta, Giuseppe Mesiano, Giulia Ferrero, Ivana Fagioli, Franca Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title | Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title_full | Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title_fullStr | Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title_full_unstemmed | Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title_short | Cytokine-Induced Killer (CIK) Cells, In Vitro Expanded under Good Manufacturing Process (GMP) Conditions, Remain Stable over Time after Cryopreservation |
title_sort | cytokine-induced killer (cik) cells, in vitro expanded under good manufacturing process (gmp) conditions, remain stable over time after cryopreservation |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281026/ https://www.ncbi.nlm.nih.gov/pubmed/32408620 http://dx.doi.org/10.3390/ph13050093 |
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