Claims for Patent: 5,616,693

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Summary for Patent: 5,616,693

Title:	Process for seperating alpha-1-proteinase inhibitor from COHN IV1 +1V4 paste
Abstract:	The present invention is directed to a process for purifying alpha-1-PI. The process comprises providing an impure protein fraction which comprises alpha-1-PI. The impure protein fraction is suspended in an aqueous solution at pH 6. Insoluble proteins are recovered and resuspended in aqueous solution at pH 8.5. PEG is added to precipitate α-2 proteins. To the PEG supernatant precipitation, which comprises alpha-1-PI, is added ZnCl2 to precipitate crude alpha-1-PI. The crude alpha-1-PI is resolubilized and applied to an anion-exchange medium. A fraction comprising alpha-1-PI is recovered from the anion-exchange medium. Alpha-1-PI purified by the process has a specific activity about 1.0 units/OD280.
Inventor(s):	Duk S. Hwang, Evelyn Nario, Mark Lepe, Lyndon Luz, Hirokazu Ito, Kazuo Takechi
Assignee:	Baxalta GmbH , Baxalta Inc
Application Number:	US08/673,064

Details for Patent 5,616,693

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	December 23, 2002	5,616,693	2016-07-01
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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