Momenta Pharmaceuticals, Inc. (MNTA)

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This is a real good one -

May 17, 2018 Patent Application -

METHODS OF MANUFACTURING THERAPEUTIC PROTEINS

BACKGROUND OF THE INVENTION

The production of therapeutic proteins using mammalian cell expression systems is of growing importance within the biotechnology industry. Various culture and transfection systems have been described, but each has significant limitations.

SUMMARY OF THE INVENTION

The invention described herein is based, in part, on the discovery that the combination of cholesterol-auxotrophic cells with one or more additional selection markers can be exploited in methods of manufacturing therapeutic proteins, to avoid unexpected manufacturing complications associated with cholesterol-auxotrophic cells (e.g., low productivity). In one aspect, the disclosure features methods of manufacturing a therapeutic protein, the method comprising: culturing a cholesterol- auxotrophic and glutamine-auxotrophic cell; transfecting the cell with (i) a nucleic acid encoding a protein which is capable of restoring cholesterol biosynthesis in the cell; (ii) a nucleic acid encoding a protein which is capable of restoring glutamine biosynthesis in the cell; and (iii) a nucleic acid encoding the therapeutic protein; culturing the cell under conditions suitable for expression of the therapeutic protein; and isolating and/or purifying the therapeutic protein.

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https://worldwide.espacenet.com/publicationDetails/description?CC=US&NR=2018135090A1&KC=A1&FT=D&ND=3&date=20180517&DB=EPODOC&locale=en_EP