Claims for Patent: 5,212,081

Summary for Patent: 5,212,081

Title:	Stabilization of polypeptide fragments against proteolytic degradation
Abstract:	Enzyme-donor fragments and other unstructured peptides are stabilized against proteolytic degradation by including a mixture of soluble, random-sequence peptides in the assay medium or in the medium in which the enzyme-donor fragment or other peptide is stored.
Inventor(s):	Coty; Bill (Danville, CA), Khanna; Pyare (Fremont, CA)
Assignee:	Microgenics Corporation (Concord, CA)
Application Number:	07/503,836
Patent Claims:	1. A method of stabilizing a beta-galactosidase enzyme-donor fragment in a complementation assay which comprises: including in an assay medium in which said assay is carried out a mixture of soluble, random-sequence peptides, wherein said mixture comprises a hydrolysate of bovine serum albumin or human serum proteins, in an amount sufficient to reduce proteolytic degradation of said enzyme-donor fragment. 2. A composition for stabilizing an enzyme-donor fragment form beta-galactosidase against proteolytic degradation in a complementation assay, which comprises a solution containing said enzyme-donor fragment and a mixture of soluble, random-sequence peptides, herein said mixture comprises a hydrolysate of bovine serum albumin or human serum proteins, in an amount sufficient to stabilize said fragment against proteolysis when said composition is added to a serum sample. 3. The composition of claim 2, wherein said peptides and said fragment are present at a weight ratio of at least 10:1. 4. A method of stabilizing a biologically active, linear peptide substantially without secondary structure against proteolytic degradation, which comprises: including in a medium which contains said active peptide and in which said proteolytic cleavage occurs a mixture of soluble, random-sequence peptides, wherein said mixture comprises a hydrolysate of bovine serum albumin or human serum proteins, in an amount sufficient to reduce proteolysis of said active peptide.

Details for Patent 5,212,081

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2040-01-28