Claims for Patent: 4,226,747

Summary for Patent: 4,226,747

Title:	Immunological diagnostic reagents comprising thio-amine terminated latex particles
Abstract:	A reagent for an immunological determination comprising water insoluble latex particles being formed from vinyl polymerizates and having free terminal functional groups of the formula: ##STR1## through which are bound an immunologically active material including materials for preparing this reagent and for utilizing this reagent for diagnostic purposes. The latex particles contain a core and an outer layer, said core being formed by polymerization of vinyl, or diene monomers or mixtures thereof with said polymerizates in said core carrying a functional group selected from group consisting of carboxyl, sulfonate or mixtures thereof and said outer layer being formed from vinyl polymerizates carrying said terminal functional group.
Inventor(s):	Roncari; Gaetano (Ettingen, CH)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	05/929,410
Patent Claims:	1. A reagent for an immunological determination comprising a water insoluble reagent in the form of discrete latex particles, said reagent having a specific weight corresponding to about that of water, said latex particles being formed from vinyl polymerizates and having free terminal functional groups of the formula ##STR7## through which is bound an immunologically active material, wherein said latex particles contain a core and an outer layer, said core containing polymerizates formed from vinyl or dienes monomers or mixtures thereof, with said polymerizates in said core carrying a functional group selected from the group consisting of carboxyl, sulfonate or mixtures thereof and said outer layer containing vinyl polymerizates carrying said terminal funtional groups. 2. The reagent of claim 1, wherein said latex particles have an average diameter of from about 0.03 .mu.m to about 5 .mu.m. 3. The reagent of claim 2, wherein the vinyl polymerizates are homopolymerizates of monomers selected from the group consisting of vinyl chloride, vinylidene chloride, vinyl acetate, acryl derivatives, styrene and styrene derivatives, copolymerizates of said monomers with one another or copolymerizates of said monomers with modified vinyl comonomers which constitute up to 5 wt.% of the copolymerizate. 4. The reagent of claim 2 wherein the diene polymerizates are homopolymerizates of a diene monomer selected from the group consisting of butadiene and its derivatives or copolymerizates of said diene monomers with one another, with vinyl monomers, with modified vinyl comonomers constituting up to 5 wt.% of the copolymerizate, or with mixtures thereof. 5. The reagent of claim 3, wherein the vinyl polymerizates which form the outer layer are homopolymerizates of olefin monomers selected from the group consisting of styrene, styrene derivatives, alkyl acrylates, alkyl methacrylates, acrylonitrile and methacrylonitrile, or copolymerizates of said olefin monomers, or copolymerizates of said olefin monomers with modified acting vinyl comonomers wherein the said vinyl comonomers constitute up to 5 wt.% of the copolymerizates. 6. A reagent according to any one of claim 2, wherein the core polymerizate comprises from about 30 wt.% to about 99.5 wt.% of the latex particle and the polymerizate of the outer layer constitutes from about 70 wt.% to about 0.5 wt.% of the latex particle. 7. The reagent of claim 1, wherein the amount of immunologically active material is from about 0.01 wt.% to about 15.0 wt.% based upon the latex. 8. The reagent of claim 7, wherein the immunologically active material is bound covalently to said terminal functional groups on the discrete latex particles. 9. The reagent of claim 1, wherein the immunologically active material is human immunoglobulin G. 10. The reagent of claim 1, wherein the immunologically active material is goat anti-human albumin immunoglobulin G. 11. The reagent of claim 1, wherein the immunologically active material is sheep anti-human IgG immunoglobulin G. 12. The reagent of claim 1, wherein the immunologically active material is bound to the latex through the diazotization of the terminal functional group. 13. The reagent of claim 1 wherein the immunologically active material is bound to the latex by means of a bifunctional compound which reacts with the free terminal functional group of the latex and the immunologically active material. 14. A process for preparing a reagent for immunological determination comprising reacting discrete latex particles formed from vinyl polymerizates and having a specific weight corresponding to about that of water and having free terminal functional group of the formula: ##STR8## with an immunologically active material, wherein said latex particles contain a core and an outer layer, said core formed by polymerization of vinyl, or diene monomers or mixtures thereof with said polymerizates in said core carrying a functional group selected from group consisting of carboxyl, sulfonate or mixtures thereof and said outer layer formed from vinyl polymerizates carrying said terminal functional group. 15. The process of claim 14 wherein the latex particles have a diameter of about 0.03 .mu.m to about 5 .mu.m. 16. The process of claim 15 wherein the immunologically active material is bound to the latex through the diazotization of said function terminal group. 17. The process of claim 16 wherein said immunologically active material is denatured immunoglobulin G. 18. The process of claim 15 wherein the immunologically active material is goat anti-human albumin immonoblogulin G. 19. The process of claim 15 wherein the immunologically active material is bound to said terminal functional groups of said latex through a bifunctional compound. 20. The process of claim 19 wherein said bifunction compound is p-phenyl diisothiocyanate or bis-diazobenzidine.

Details for Patent 4,226,747

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		1997-10-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		1997-10-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		1997-10-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		1997-10-07
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		1997-10-07
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	02/06/2017		1997-10-07