A sandwich ELISA for the quantification of the anticancer peptide CIGB-552 in human plasma.

Autor: Gómez Hernández NA; Pharmaceutical Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: nivaldo.gomez@cigb.edu.cu., Pérez GL; Chemistry-Physics Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: gilda.lemos@cigb.edu.cu., Arteaga AV; Chemistry-Physics Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: amalia.vazquez@cigb.edu.cu., Garay Pérez HE; Peptide Synthesis Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: hilda.garay@cigb.edu.cu., Arguellez BO; Pharmaceutical Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: brizaida.oliva@cigb.edu.cu., Rico AC; Chemistry-Physics Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: ania.cabrales@cigb.edu.cu., Guardia AL; Monoclonal Antibody Production Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: airela.llamo@cigb.edu.cu., Fernández Massó JR; Pharmaceutical Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. Electronic address: julio.fernandez@cigb.edu.cu.
Jazyk: angličtina
Zdroj: Analytical biochemistry [Anal Biochem] 2024 Nov 27; Vol. 698, pp. 115725. Date of Electronic Publication: 2024 Nov 27.
DOI: 10.1016/j.ab.2024.115725
Abstrakt: CIGB-552 is a synthetic anticancer peptide that has been evaluated in vitro and in vivo in lung and colon cancer models. To optimize therapy in the clinic, pharmacokinetic studies are necessary. Previously, a sandwich-type enzyme-linked immunosorbent assay (ELISA) had been developed by our working group for the quantification of CIGB-552 in biological matrices. The objective of this work was to carry out the full validation of the ELISA to support its application in clinical trials. First, we obtained a polyclonal antibody specific for CIGB-552 and with purity greater than 95 %. The lower limit of quantification and the upper limit of quantification were 3125 ng/ml and 200 ng/ml, respectively. The method is exact and precise in the quantification of the peptide with relative error and coefficient of variation values less than 20 %. The ELISA is specific in the presence of CIGB-552 metabolites in the sample, and also presents robustness to certain protocol variations. In summary, the validated ELISA meets the requirements for its application in upcoming clinical trials as part of pharmacokinetic studies.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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