Charge Variants of an Avastin Biosimilar Isolation,Characterization, In Vitro Properties and Pharmacokinetics in Rat |
| |
| Authors: | Yan-Yan Zhao Ning Wang Wan-Hui Liu Wen-Jie Tao Li-Li Liu Zhen-Duo Shen |
| |
| Affiliation: | 1. School of Pharmacy, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Yantai University, Yantai, 264005, P.R. China;2. State Key Laboratory of Long-acting and Targeting Drug Delivery System, Luye Pharma Group Ltd., Yantai, 264005, P.R. China;Kermanshah University of Medical Sciences, ISLAMIC REPUBLIC OF IRAN |
| |
| Abstract: | The similarity between a proposed biosimilar product and the reference product can be affected by many factors. This study is designed to examine whether any subtle difference in the distribution of the charge variants of an Avastin biosimilar can affect its in vitro potency and in vivo PK. Here, the acidic, basic and main peak fractions of a biosimilar product were isolated using high-performance cation-exchange chromatography and were subjected to various studies to compare their in vitro properties and in vivo PK profile. A serial of analytical methods, including size exclusion chromatography (SEC), imaged capillary isoelectric focusing (icIEF) capillary zone electrophoresis (CZE) and cation-exchange chromatography (CEX-HPLC) were also used to characterize the isolated charge variants. The kinetics constant was measured using a Biacore X100 system. The study indicates the biosimilar product has a high similarity with avastin in physicochemical properties. The potency in vitro and PK profile in rat of charge variants and biosimilar product are consistent with avastin. |
| |
| Keywords: | |
|
|
