High Bio-physico-chemical Comparability of VMB-015, a Vedolizumab Biosimilar, with the Originator Drug Entyvio®
عنوان دوره: 1
1Kamran Khalili؛ 1Hossein Rahmani؛ 2Saemeh Asgari؛ 3Farzad Khanipour؛ 4Morteza Jafaraghaei؛ 5Amir Maghsoudi
1Analytical assay Laboratory, Quality Control Department, PersisGen Par Company.
2Quality Control Supervisor, Quality Control Department, PersisGen Par Company.
3Scientific and technical information, R&D Department, PersisGen Par Company
4Deputy Director, R&D Department, PersisGen Par Company.
5Manager, R&D Department, PersisGen Par Company.
Vedolizumab is a humanized IgG-1 therapeutic monoclonal antibody (mAb) Produced recombinantly in Chinese hamster ovary (CHO) cells, which is marketed under the trade name Entyvio® by Takeda Pharmaceuticals. It was approved by the US FDA for treatment of Ulcerative Colitis and Crohn's Disease in 2014. Vedolizumab selectively targets α4β7 Integrin expressed on lymphocyte cell surfaces, blocking its interaction with MAdCAM-1, and thus rendering specific modulation of the inflammatory pathways in the gastrointestinal tract. This article is the first report on development of a vedolizumab biosimilar (VMB-015), carried out by PersisGen Par Co. The nonclinical comparative analytical assessment of VMB-015 included peptide mapping, glycan mapping, charge variants analysis, purity analysis, bioactivity analysis, and analysis of drug osmolality, coloration, clarity and opalescence. The results unanimously demonstrated the high degree of VMB-015 comparability with Entyvio®, which confirmed the high quality of manufacturing process development in PersisGen Par Co. biopharmaceutical developer.