{"title":"A sandwich ELISA for the quantification of the anticancer peptide CIGB-552 in human plasma.","authors":"Nivaldo Angel Gómez Hernández, Gilda Lemos Pérez, Amalia Vazquez Arteaga, Hilda Elisa Garay Pérez, Brizaida Oliva Arguellez, Ania Cabrales Rico, Airela Llamo Guardia, Julio Raúl Fernández Massó","doi":"10.1016/j.ab.2024.115725","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":7830,"journal":{"name":"Analytical biochemistry","volume":" ","pages":"115725"},"PeriodicalIF":2.6000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Analytical biochemistry","FirstCategoryId":"99","ListUrlMain":"https://doi.org/10.1016/j.ab.2024.115725","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍:
The journal''s title Analytical Biochemistry: Methods in the Biological Sciences declares its broad scope: methods for the basic biological sciences that include biochemistry, molecular genetics, cell biology, proteomics, immunology, bioinformatics and wherever the frontiers of research take the field.
The emphasis is on methods from the strictly analytical to the more preparative that would include novel approaches to protein purification as well as improvements in cell and organ culture. The actual techniques are equally inclusive ranging from aptamers to zymology.
The journal has been particularly active in:
-Analytical techniques for biological molecules-
Aptamer selection and utilization-
Biosensors-
Chromatography-
Cloning, sequencing and mutagenesis-
Electrochemical methods-
Electrophoresis-
Enzyme characterization methods-
Immunological approaches-
Mass spectrometry of proteins and nucleic acids-
Metabolomics-
Nano level techniques-
Optical spectroscopy in all its forms.
The journal is reluctant to include most drug and strictly clinical studies as there are more suitable publication platforms for these types of papers.