Development and validation of bioanalytical methods to support clinical study of disitamab vedotin.
Bioanalysis
; 16(9): 385-400, 2024.
Article
in En
| MEDLINE
| ID: mdl-38530234
ABSTRACT
Disitamab vedotin (RC48), a humanized anti-HER2 antibody conjugated with monomethyl auristatin E (MMAE), is the first antibody-drug conjugate in China with an approved biological license application. A bioanalytical method was established for three analytes (total antibody, conjugate antibody and free payload) to help characterize their pharmacokinetic behavior in clinical settings. The bioanalytical methods were validated according to M10 guidance. Electrochemiluminescence assay methods were used for the quantitative measurement of total antibody and conjugated antibody in human serum. A LC-MS/MS method was used to quantify the concentration of MMAE in human serum. The method had high specificity and sensitivity with a quantitative range of 19.531-1250.000 ng/ml (total antibody), 39.063-5000.000 ng/ml (conjugated antibody) and 0.04-10.0 ng/ml (MMAE), respectively.
[Box see text].
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Immunoconjugates
/
Tandem Mass Spectrometry
Limits:
Humans
Language:
En
Journal:
Bioanalysis
Year:
2024
Document type:
Article
Affiliation country:
China