Comparative analytical profiling of bevacizumab biosimilars marketed in India: a national control laboratory study
In: 3 Biotech, Jg. 10 (2020-11-09)
Online
unknown
Zugriff:
In this study, analytical profiling of the bevacizumab (BVZ) biosimilars (N = 3) approved in India were evaluated for charge heterogeneity, isoelectric focusing, aggregation and in vitro potency analysis. The charge variants were characterized using high performance cation-exchange chromatography (CEX-HPLC), capillary zone electrophoresis (CZE) and capillary isoelectric focusing (cIEF). cIEF was also used for estimation of isoelectric point (pI value). In addition, aggregate analysis was done using size exclusion high performance chromatography (SEC-HPLC). The cell-based inhibition of proliferation assay using HUVEC cells, indirect ELISA and Western blot were performed for in vitro biological activity. In addition of cell-based cytotoxicity assay was also performed and found no cytotoxic effect on both HuT78 and WIL2S cells by bevacizumab biosimilars. The significant variations in acidic (p
| Titel: |
Comparative analytical profiling of bevacizumab biosimilars marketed in India: a national control laboratory study
|
|---|---|
| Autor/in / Beteiligte Person: | Anand, Apoorva ; Prakash, Anu ; Prasad, J. P. ; Mahajan, Richi V. ; Nripendra Nath Mishra ; Sharma, Sonia ; Chand, Subhash ; Vaish, Utpreksha |
| Link: | |
| Zeitschrift: | 3 Biotech, Jg. 10 (2020-11-09) |
| Veröffentlichung: | Springer Science and Business Media LLC, 2020 |
| Medientyp: | unknown |
| ISSN: | 2190-5738 (print) ; 2190-572X (print) |
| DOI: | 10.1007/s13205-020-02506-9 |
| Schlagwort: |
|
| Sonstiges: |
|