Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum.
Bioanalysis
; 14(18): 1241-1249, 2022 Sep.
Article
em En
| MEDLINE
| ID: mdl-36378607
ABSTRACT
Background:
HMBD-001 is an IgG1 humanized monoclonal antibody specifically targeting HER3, a receptor highly expressed on cancer cells in certain tumors. A bioanalytical method was required to quantify HMBD-001 in human serum, with high selectivity and without interference from HER3. Methods andresults:
A bridging ELISA using an anti-idiotypic monoclonal capture and detection was developed and validated for quantitative measurement of HMBD-001 in human serum. The assay is sensitive, with a lower limit of quantification of 250 ng/ml, has a broad dynamic range of 250-7000 ng/ml HMBD-001, and exhibits excellent precision and overall accuracy.Conclusion:
We have developed and validated a sensitive and selective method for measuring HMBD-001 in human serum. This assay is now being used in a clinical trial setting.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Soro
/
Anticorpos Monoclonais
Limite:
Humans
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Reino Unido