METHODS OF PRODUCING LONG ACTING CTP-MODIFIED POLYPEPTIDES

摘要

Disclosed herein is a method for manufacturing a recombinant polypeptide of interest modified by a CTP extension in a mammalian cells culture system.

主权项

1. A method of manufacturing a human CTP-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;
(i) wherein said transfected cells express and secrete 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 the CTP-modified polypeptide of interest.