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 desialylation/degalactosylation) was compared using the in vivo and in vitro bioassays. The in vitro bioassay reliably detected potential chemical/physical modifications in r-hFSH variants that may impact biopotency. Overall, the methods demonstrated a comparable ability to detect changes in specific activities due to chemical/physical differences in r-hFSH variants. These data indicate that the in vitro bioassay is suitable to replace the in vivo bioassay.

Biological Assay to Determine Gonadotropin Potency: From In Vivo to In Vitro Sustainable Method / Nevelli, Francesco; Palmese, Angelo; Gleixner, Ralf; Peroglio, Flavio; D'Acunto, Cosimo-Walter; Dadone, Aurora; D'Hooghe, Thomas; Lispi, Monica. - In: INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES. - ISSN 1422-0067. - 24:9(2023), pp. 8040-8040. [10.3390/ijms24098040]

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

Lispi, Monica
2023

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 desialylation/degalactosylation) was compared using the in vivo and in vitro bioassays. The in vitro bioassay reliably detected potential chemical/physical modifications in r-hFSH variants that may impact biopotency. Overall, the methods demonstrated a comparable ability to detect changes in specific activities due to chemical/physical differences in r-hFSH variants. These data indicate that the in vitro bioassay is suitable to replace the in vivo bioassay.
2023
24
9
8040
8040
Biological Assay to Determine Gonadotropin Potency: From In Vivo to In Vitro Sustainable Method / Nevelli, Francesco; Palmese, Angelo; Gleixner, Ralf; Peroglio, Flavio; D'Acunto, Cosimo-Walter; Dadone, Aurora; D'Hooghe, Thomas; Lispi, Monica. - In: INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES. - ISSN 1422-0067. - 24:9(2023), pp. 8040-8040. [10.3390/ijms24098040]
Nevelli, Francesco; Palmese, Angelo; Gleixner, Ralf; Peroglio, Flavio; D'Acunto, Cosimo-Walter; Dadone, Aurora; D'Hooghe, Thomas; Lispi, Monica
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1320667
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