Comparative study of size and charge heterogeneities of anti-TNF-αantibodies by high performance liquid chromatography
10.3760/cma.j.issn.0254-5101.2014.09.014
- VernacularTitle:TNF-α单抗分子大小变异体与电荷变异体色谱行为的比较研究
- Author:
Wei GUO
;
Wenbo WANG
;
Chuanfei YU
;
Feng ZHANG
;
Lan WANG
;
Chunyu LIU
;
Meng LI
;
Kai GAO
- Publication Type:Journal Article
- Keywords:
Monoclonal antibody;
Size heterogeneity;
Charge heterogeneity
- From:Chinese Journal of Microbiology and Immunology
2014;(9):723-726
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the differences of size and charge heterogeneities between origi-nal humanized anti-TNF-αantibody and four similar biotherapeutic products ( SBP ) .Methods The size exclusion chromatography ( SEC-HPLC ) and weak cation exchange chromatography ( WCX-HPLC ) were used to analyze the size and charge heterogeneities , respectively.Carboxypeptidase B (CpB) treatment was employed to analyze the source of charge heterogeneity of the antibody products .Results Four SBPs showed the same pattern with the originator in SEC-HPLC, and no significant difference with the percentage of mono-mer was observed .The percentages of the aggregates of SBP-3 and SBP-4 were a little higher than those of the originator .The charge distribution of SBPs was significantly different from the originator ′s, especially in the basic region .The results from the samples treated with CpB indicated that the difference of charge distri -bution in the basic region might be caused by the C-terminal lysine variants .Conclusion Four SBPs showed similar size heterogeneity with the originator , but significant differences with charge heterogeneity were observed among them .The study suggested that more attention should be paid to the charge heterogene -ity analysis of the biosimilar products .
