METHODS OF PRODUCING LONG ACTING CTP-MODIFIED POLYPEPTIDES

• Main Authors: MOSCHCOVICH, LAURA, HERSHKOVITZ, OREN
• Format: Patent
• Language: English; French
• Published: 04.08.2016
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

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. L'invention concerne une méthode de fabrication d'un polypeptide recombinant d'intérêt modifié par une extension CTP dans un système de culture de cellules de mammifère.