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Details for Patent: 5,128,453

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Details for Patent: 5,128,453

Title: Urinary follicle stimulating hormone
Abstract:Purification of human FSH from post-menopausal urine gonadotropin using immunoaffinity chromatography with elution at high pH and reverse-phase HPLC steps yields a biologically active hormone which is free from detectable traces of luteinizing hormone and other urinary proteins.
Inventor(s): Arpaia; Guiseppe (Rome, IT), Serani; Serenella (Rome, IT), Sirna; Antonino (Rome, IT), Villa; Stefano (Rome, IT)
Assignee: Istituto DiRicerca Cesare Serono SpA (Rome, IT)
Filing Date:Feb 07, 1989
Application Number:07/337,766
Claims:1. A process of preparing a biologically active urinary follicle stimulating hormone substantially free from detectable traces of luteinizing hormone and other urinary proteins which comprises subjecting a post-menopausal urinary concentrate to immunopurification using an FSH-specific immobilized monoclonal antibody, eluting said hormone using as eluent an aqueous solution having a pH higher than about 10 and anionic molarity higher than about 0.5M, removing any residual traces of contaminants by reverse phase high pressure liquid chromatography, and recovering said hormone.

2. A process according to claim 1 wherein said eluent has a pH higher than 11.

3. A process according to claim 2 wherein said eluent has an ionic molarity higher than 0.8M.

4. A process according to claim 3 wherein said eluent has a pH within the range of 11.3 to 11.7.

5. A process according to claim 4 wherein said eluent is 1M ammonia.

6. A process according to claims 1, 2, 3, 4, or 5 wherein said FSH-specific immobilized monoclonal antibody has the following specifications:

a) protein purity: not less than 90%

b) class of immunoglobulin: IgG 1

c) specificity:

d) binding capacity to FSH in solution: about 1,000 I.U. FSH per mg monoclonal antibody.

7. A process according to claim 6 wherein said monoclonal antibody has an affinity constant of about 3.5.times.10.sup.8 L. mole.sup.-1.

8. A process according to claim 6 wherein said hormone is recovered by use of a gradient of isopropanol up to 50% of the mobile phase in the reverse phase high pressure liquid chromatography.

9. A process according to claim 6 wherein said post-menopausal urinary concentrate is human menopausal gonadotropin.

10. A process according to claim 6 wherein said recovered hormone has a specific activity not lower than 6200 I.U. of FSH per milligram of lyophilized powder.

11. A process according to claim 6 wherein said recovered hormone is in glycosylated form.
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