title: Recombinant human thyroid-stimulating hormone: initial bioactivity assessment using human fetal thyroid cells.
abstract: We have assessed the bioactivity of newly available recombinant human TSH (rec-hTSH) using human fetal thyroid cells, with the longer term aim of assessing its use for clinical applications. Rec-hTSH caused a consistent and dose-related increase in thyroid monolayer cell cAMP release and human thyroglobulin (hTg) secretion, confirming its bioactivity. Repetitive studies (n = 5) allowed us to derive an estimated biopotency for the rec-hTSH preparation examined of 5.6 IU/mg compared to 10 IU/mg for commercially available bovine TSH for human use. The rec-hTSH had a bioimmune ratio of 0.55, similar to that of purified pituitary hTSH standards, Furthermore, rec-hTSH induced thyroid epithelial cell growth, as evidenced by a decrease in thyroid cell doubling time from 54 +/- 2.1 to 31 +/- 1.7 h (P less than 0.005). Hence, rec-hTSH is a potent glycoprotein hormone preparation when measured in a homologous human thyroid cell culture system. Rec-hTSH could serve as a future definitive International Standard and has the potential for a useful diagnostic and therapeutic reagent.
authors.affiliation: Department of Medicine, Mount Sinai School of Medicine, New York, New York 10029.
authors.forename: G K
authors.initials: GK
authors.lastname: Huber
authors.forename: P
authors.initials: P
authors.lastname: Fong
authors.forename: E S
authors.initials: ES
authors.lastname: Concepcion
authors.forename: T F
authors.initials: TF
authors.lastname: Davies
mesh_terms: D002455:Cell Division; D000242:Cyclic AMP / Q000378:metabolism; D004847:Epithelial Cells; D005333:Fetus; D006801:Humans; D011994:Recombinant Proteins; D013954:Thyroglobulin / Q000378:metabolism; D013961:Thyroid Gland / Q000166:cytology / Q000187:drug effects* / Q000196:embryology; D013972:Thyrotropin / Q000494:pharmacology*
chemical_list: D011994:Recombinant Proteins; D013972:Thyrotropin; D013954:Thyroglobulin; D000242:Cyclic AMP