Quantification of anti-CD22 monoclonal antibody concentration by enzyme-immunoassay
ZHANG Hai-xia
LI Zheng-dong
ZENG Pei-fang
LI Su
HUANG Pei-fen
Abstract：Objective: To establish methods for determining the serum levels of SM03 in patients treated with the antibody for clinical pharmacokinetic studies. Methods: Bacterial expression of B epitope of human CD22 and an-ti-idiotype antibody (LRID03) against SM03 were developed, and were used as the surrogate antigen for the evalua-tion of serum levels of SM03 in both competition ELISA (C-ELISA) and sandwich ELISA (S-ELISA) assays. The two methods were validated and compared in terms of their sensitivity and specificity towards determining serum con-centration of SM03. Results: Both S-ELISA and C-ELISA assays showed good accuracy and specificity for determining SM03 concentration in serum. Conclusion :S-ELISA with LRID03 anti-idiotype antibody appeared to be more sensi-tive, stable, and reproducible, and was therefore used as the standard method for subsequent clinical pharmacokinetic studies.
Keywords：ELISACD22SM03anti-diotypic antibodypharmacokinetics
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 253-257 )