Biological Assay to Determine Gonadotropin Potency: From In Vivo to In Vitro Sustainable Method.

ABSTRACT: Various preparations of follicle-stimulating hormone (FSH) are commercially available; however, they differ in glycoforms composition and purity owing to their respective sources. Additional chemical/physical changes can also be introduced during manufacturing and can impact their biological activity (biopotency), which is routinely assessed using an in vivo bioassay (Steelman-Pohley). This study aimed to determine whether an in vitro bioassay could assess biopotency by distinguishing between r-hFSH chemical/physical variants with similar ability to the in vivo bioassay. The specific activity (units of biological activity per mg of product) of variants of r-hFSH generated through enrichment (acidic/basic), stress (oxidative/acidic pH) and enzymatic treatment (desialylation and desialylatio

SUBMITTER: Nevelli F 

PROVIDER: S-EPMC10178553 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature