Study question: Can an in-vitro bioassay assess the potency of r-hFSH-alfa force-degraded variants with similar ability to the in-vivo rat bioassay described in EU Pharmacopoeia (EU-Pharm 2285) ? Summary answer: The in-vitro bioassay showed similar ability to the in-vivo bioassay for estimating the impact of r-hFSH-alfa variants, resulting from process-related modifications, on biological activity.
P-635 The impact of force-degraded variants of recombinant human follicle stimulating hormone alfa (r-hFSH alfa) on in-vitro and in-vivo biological activity / Nevelli, F; Peroglio, F; Gleixner, R; Dadone, A; Palmese, A; Lispi, M; D'Hooghe, T; D’Acunto, C. W.. - In: HUMAN REPRODUCTION. - ISSN 1460-2350. - 37:Supplement_1(2022), pp. i486-i487.
P-635 The impact of force-degraded variants of recombinant human follicle stimulating hormone alfa (r-hFSH alfa) on in-vitro and in-vivo biological activity
M Lispi
;
2022
Abstract
Study question: Can an in-vitro bioassay assess the potency of r-hFSH-alfa force-degraded variants with similar ability to the in-vivo rat bioassay described in EU Pharmacopoeia (EU-Pharm 2285) ? Summary answer: The in-vitro bioassay showed similar ability to the in-vivo bioassay for estimating the impact of r-hFSH-alfa variants, resulting from process-related modifications, on biological activity.
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Descrizione: The impact of force-degraded variants of recombinant human follicle stimulating hormone alfa (r-hFSH alfa) on in-vitro and in-vivo biological activity
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