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Title:
METHODS OF PRODUCING LONG ACTING CTP-MODIFIED POLYPEPTIDES
Document Type and Number:
WIPO Patent Application WO/2016/092550
Kind Code:
A3
Abstract:
Disclosed herein is a method for manufacturing a recombinant polypeptide of interest modified by a CTP extension in a mammalian cells culture system. In one aspect, disclosed herein is a method of manufacturing a human chorionic gonadotropin carboxy terminal peptide (ClP)-modified polypeptide of interest, the method comprising the steps of: (a) stably transfecting a predetermined number of cells with an expression vector comprising a coding portion encoding said CTP-modified polypeptide of interest, wherein said transfected cell expresses and secretes said CTP-modified polypeptide of interest; (b) obtaining cell clones that overexpress said CTP-modified polypeptide of interest; (c) expanding said clones in solution to a predetermined scale; (d) harvesting said solution containing said clones; (e) filtering said solution containing said clones to obtain a clarified harvest solution; and, (f) purifying said clarified harvest solution to obtain a purified protein solution having a desired concentration of a CTP-modified polypeptide of interest, thereby manufacturing a human chorionic gonadotropin peptide (CTP)-modified polypeptide of interest.

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Inventors:
HERSHKOVITZ OREN (IL)
MOSCHCOVICH LAURA (IL)
Application Number:
PCT/IL2015/051197
Publication Date:
August 04, 2016
Filing Date:
December 10, 2015
Export Citation:
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Assignee:
OPKO BIOLOG LTD (IL)
International Classes:
A61K38/22
Domestic Patent References:
WO1994024148A11994-10-27
Foreign References:
US20140113860A12014-04-24
US20140316112A12014-10-23
US7091326B22006-08-15
Other References:
SUGAHARA ET AL.: "Characterization of the O-Glycosylation Sites in the Chorionic Gonadotropin b Subunit in Vivo Using Site-directed Mutagenesis and Gene Transfer", THE JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 271, no. 34, 23 August 1996 (1996-08-23), pages 20797 - 20804, XP055385308
Attorney, Agent or Firm:
COHEN, Mark S. (P.O.Box 12704, 49 Herzliya, IL)
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