Patent: 5,976,529

Summary for Patent: 5,976,529

Title:	Methods of enzyme therapy by orally administering crosslinked enzyme crystals
Abstract:	A protein such as an enzyme or antibody is immobilized by crosslinking crystals of the protein with a multifunctional crosslinking agent. The crosslinked protein crystals may be lyophilized for storage. A preferred protein is an enzyme such as thermolysin, elastase, asparaginase, lysozyme, lipase or urease. Crosslinked enzyme crystals preferably retain at least 91% activity after incubation for three hours in the presence of a concentration of Pronase.TM. that causes the soluble uncrosslinked form of the enzyme to lose at least 94% of its initial activity under the same conditions. A preferred enzyme:Pronase.TM. ratio is 1:40. Enzyme crystals that are crosslinked may be microcrystals having a cross-section of 10.sup.-1 mm or less. Crosslinked enzyme or antibody crystals may be used in an assay, diagnostic kit or biosensor for detecting an analyte, in an extracorporeal device for altering a component of a fluid, in producing a product such as using crosslinked thermolysin crystals to produce aspartame and in separating a substance from a mixture. Enzyme therapy such as lipase therapy can be performed by administering orally crosslinked lipase crystals.
Inventor(s):	Navia; Manuel A. (Lexington, MA), St. Clair; Nancy L. (Charlestown, MA)
Assignee:	Vertex Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	08/477,109
Patent Claims:	see list of patent claims

Details for Patent 5,976,529

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2016-11-02