Claims for Patent: 8,512,706

Summary for Patent: 8,512,706

Title:	Compositions of F(ab\').sub.2 antibody fragments
Abstract:	The present invention is directed to a pharmaceutical composition comprising F(ab\').sub.2 antibody fragments that are preferably free from albumin and of whole antibodies and also substantially free of pyrogens, and an effective amount of a pharmaceutically acceptable carrier. It is also directed to a method for the production of a pharmaceutical composition comprising F(ab\').sub.2 antibody fragments using scrum or blood plasma of a mammal that has been previously immunized as a source of antibodies. The serum or blood plasma is digested with an enzyme pepsin, followed by separation and purification until the pharmaceutical composition of F(ab\').sub.2 fragments is free of albumin and complete antibodies, and substantially free of pyrogens.
Inventor(s):	Lopez De Silanes; Juan (Mexico City, MX), Mancilla Nava; Rita Guadalupe (Mexico City, MX), Paniagua-Solis; Jorge F. (Mexico City, MX), Alagon Cano; Alejandro (Cuernavaca, MX), Garcia-Ubbelohde; Walter J. (Mexico City, MX)
Assignee:	Instituto Bioclon, S.A. DE C.V. (Mexico City, MX)
Application Number:	13/298,778
Patent Claims:	1. A composition comprising F(ab').sub.2 antibody fragments substantially free from albumin and whole antibodies and substantially free of pyrogens, wherein the composition binds to a purified antigenic molecule or a mixture of antigenic molecules found in spider venom, and wherein the F(ab').sub.2 antibody fragments are obtained by a method which comprises: (a) contacting a source of antibodies with pepsin under conditions to prepare an antibody digest containing F(ab').sub.2 antibody fragments, wherein the antibody digest is substantially free of unhydrolyzed antibodies; and (b) treating the antibody digest with two steps of ammonium sulfate precipitation, (i) one step at about 16% to about 22% weight by volume of ammonium sulfate, and (ii) another step at about 32% to about 38% weight by volume of ammonium sulfate, to thereby obtain a suspension containing F(ab').sub.2 antibody fragments substantially free of whole antibodies. 2. The composition of claim 1, further comprising a pharmaceutically acceptable carrier. 3. The composition of claim 1, wherein the composition is substantially free of viral particles. 4. The composition of claim 1, wherein the spider venom is from a spider of the genus Latrodectus. 5. The composition of claim 4, wherein the spider venom is from a black widow spider (Latrodectus mactans). 6. The composition of claim 1, wherein the method further comprises generating a source of antibodies from an animal that has been immunized with a mixture of antigenic molecules found in the spider venom prior to the contacting. 7. The composition of claim 1, wherein the F(ab').sub.2 antibody fragments are polyclonal F(ab').sub.2 antibody fragments. 8. The composition of claim 1, wherein the composition neutralizes a purified antigenic molecule or a mixture of antigenic molecules found in the spider venom. 9. A composition comprising F(ab').sub.2 antibody fragments substantially free from albumin and whole antibodies and substantially free of pyrogens, wherein the composition binds to a purified antigenic molecule or a mixture of antigenic molecules found in spider venom, and wherein the F(ab').sub.2 antibody fragments are obtained by a method which comprises: (a) generating a source of antibodies from an animal that has been immunized with a mixture of antigenic molecules found in spider venom; (b) contacting the source of antibodies with pepsin under conditions to prepare an antibody digest containing F(ab').sub.2 antibody fragments, wherein the antibody digest is substantially free of unhydrolyzed antibodies; (c) treating the antibody digest with two steps of ammonium sulfate precipitation, (i) one step at about 16% to about 22% weight by volume of ammonium sulfate, and (ii) another step at about 32% to about 38% weight by volume of ammonium sulfate, to thereby obtain a suspension containing F(ab').sub.2 antibody fragments substantially free of whole antibodies; (d) centrifuging the suspension to produce a composition comprising a paste of F(ab').sub.2 antibody fragments and a supernatant; and (e) removing the supernatant from the composition of (d). 10. The composition of claim 9, further comprising a pharmaceutically acceptable carrier. 11. The composition of claim 9, wherein the composition is substantially free of viral particles. 12. The composition of claim 9, wherein the spider venom is from a spider of the genus Latrodectus. 13. The composition of claim 12, wherein the spider venom is from a black widow spider (Latrodectus mactans). 14. The composition of claim 9, wherein the F(ab').sub.2 antibody fragments are polyclonal F(ab').sub.2 antibody fragments. 15. The composition of claim 9, wherein the composition neutralizes a purified antigenic molecule or a mixture of antigenic molecules found in spider venom.

Details for Patent 8,512,706

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	LACTRODECTUS MACTANS	antivenin (latrodectus mactans)	For Injection	101062	02/13/1936		2021-03-05