Lucio Manzi, Nunzio Sepe, Walter Migliaccio, Ludovica Lanzoni, Luisa Iozzino, Fabrizia D'Angelo, Lucia Colarusso, Susana Montenegro, Angelo Palmese, Thomas D'Hooghe, Alfredo Ulloa-Aguirre, Yulia Koloda, Monica Lispi
Although the full primary structures of the alfa and beta subunits of reference r-hFSH-alfa and its biosimilars are identical, cell context-dependent differences in the expressing cell lines and manufacturing process can lead to variations in glycosylation profiles. In the present study, we compared the structural features of reference r-hFSH-alfa with those of five biosimilar preparations approved in different global regions outside Europe (Primapur® , Jin Sai Heng® , Follitrope® , Folisurge® , and Corneumon® ) with respect to glycosylation, macro- and microheterogeneity, and other post-translational modifications and higher order structure...
June 17, 2022: International Journal of Molecular Sciences