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Last Updated: December 27, 2024

Claims for Patent: 10,208,101

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Summary for Patent: 10,208,101

Title:	Recombinant fibrinogen high-production line and method for producing same
Abstract:	The present invention provides a recombinant strain highly producing fibrinogen which is an animal cell strain coexpressing a fibrinogen and an .alpha.2PI and/or PAI-2, genes encoding A.alpha. chain, B.beta. chain and .gamma. chain of fibrinogen, a production method of a recombinant strain highly producing fibrinogen, including introducing gene(s) encoding .alpha.2PI and/or PAI-2 into an animal cell, and coexpressing fibrinogen and .alpha.2PI and/or PAI-2 in the animal cell, and a production method of a recombinant fibrinogen including culturing a recombinant strain highly producing fibrinogen in a medium, and recovering fibrinogen from the obtained culture.
Inventor(s):	Uno; Shusei (Tokyo, JP), Otaki; Momoko (Tokyo, JP), Murakami; Kouji (Tokyo, JP), Ideno; Shoji (Tokyo, JP)
Assignee:	JAPAN BLOOD PRODUCTS ORGANIZATION (Tokyo, JP)
Application Number:	15/108,194
Patent Claims:	1. A recombinant animal cell comprising genes encoding the A.alpha. chain, B.beta. chain, and .gamma. chain of fibrinogen and gene(s) encoding .alpha.2 plasmin inhibitor (.alpha.2PI) and/or plasminogen activator inhibitor-2 (PAI-2), wherein functional fibrinogen is produced by coexpressing said fibrinogen genes with .alpha.2PI and/or PAI-2 in said animal cell, and wherein said cell suppresses degradation of fibrinogen during cell culture and/or increases the production amount of fibrinogen independent of the suppressive effect, compared to the same animal cell expressing fibrinogen but which does not coexpress .alpha.2PI and/or PAI-2. 2. The recombinant cell according to claim 1, wherein the fibrinogen and .alpha.2PI and/or PAI-2 are human fibrinogen and human c2PI and/or PAI-2. 3. The recombinant cell according to claim 1, wherein the animal cell is a Chinese hamster ovary (CHO) cell strain. 4. A method of making a recombinant animal cell that produces fibrinogen, comprising introducing genes encoding A.alpha. chain, B.beta. chain and .gamma. chain of fibrinogen, and gene(s) encoding a2 plasmin inhibitor (a2PI) and/or plasminogen activator inhibitor-2 (PAI-2) into an animal cell, and coexpressing the fibrinogen and a2PI and/or PAI-2 in the animal cell, wherein said cell suppresses degradation of fibrinogen during cell culture and/or increases the production amount of fibrinogen independent of the suppressive effect, compared to an animal cell expressing fibrinogen but which does not coexpress .alpha.2PI and/or PAI-2. 5. The method according to claim 4, comprising expressing fibrinogen in the animal cell by using a single expression vector comprising all of genes encoding A.alpha. chain, B.beta. chain and .gamma. chain of fibrinogen. 6. The method according to claim 4, comprising expressing .alpha.2PI and PAI-2 in the animal cell by using a single expression vector comprising a gene encoding .alpha.2PI and a gene encoding PAI-2. 7. The method according to claim 4, wherein the genes encoding A.alpha. chain, B.beta. chain and .gamma. chain of fibrinogen and the gene(s) encoding .alpha.2PI and/or PAI-2 are each a human gene. 8. The method according to claim 4, wherein the animal cell is a CHO cell. 9. A production method of a recombinant fibrinogen, comprising culturing the recombinant animal cell according to claim 1 in a medium, and recovering fibrinogen from the obtained culture. 10. A production method of a recombinant fibrinogen, comprising culturing the fibrinogen producing recombinant animal cell, obtained by the method according to claim 4, in a medium, and recovering fibrinogen from the obtained culture.

Details for Patent 10,208,101

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	January 16, 2009	⤷ Subscribe	2033-12-27
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	June 07, 2017	⤷ Subscribe	2033-12-27
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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