Claims for Patent: 6,030,792

Summary for Patent: 6,030,792

Title:	Assays for measurement of protein fragments in biological media
Abstract:	This invention provides novel antibodies and engineered versions thereof and methodology for monitoring biological media for protein fragments, especially collagen fragments resulting from collagenase cleavage of type II collagen.
Inventor(s):	Otterness; Ivan G. (Groton, CT), Mezes; Peter S. (Old Lyme, CT), Downs; James T. (Norwich, CT), Johnson; Kimberly S. (Gales Ferry, CT)
Assignee:	Pfizer Inc (New York, NY)
Application Number:	09/184,658
Patent Claims:	1. A method for monitoring biological media for protein fragments which comprises; contacting said biological media with a capture antibody; said capture antibody being active against the sequences set forth in the Sequence Listing as SEQ ID NOS: 1 and 2; and contacting said biological media with a detection antibody; said capture antibody being active against the sequences set forth in the Sequence Listing as SEQ ID NOS: 3 and 4; and detecting the amount of collagen fragments bound to said capture and detection antibodies; or contacting said biological media with a capture antibody; said capture antibody being active against the sequences set forth in the Sequence Listing as SEQ ID NOS: 3 and 4; and contacting said biological media with a detection antibody; said detection antibody being active against the sequences set forth in the Sequence Listing as SEQ ID NOS: 1 and 2; and detecting the amount of collagen fragments bound to said capture and detection antibodies. 2. A method of claim 1 wherein said protein fragments are collagen fragments generated by collagenase cleavage of articular cartilage. 3. A method of claim 2 wherein said protein fragments are generated from collagenase cleavage of type II collagen. 4. A method of claim 2 wherein said capture and detection antibodies are monoclonal antibodies. 5. A method of claim 1 wherein said capture and detection antibodies are monoclonal antibodies. 6. A method of claim 1 wherein said capture antibody is a genetically engineered antibody. 7. A method of claim 1 wherein said detection antibody is a genetically engineered antibody. 8. A method of claim 1 wherein said capture antibody, designated 9A4, has the V.sub.H sequence as set forth in the Sequence Listing as SEQ ID NOS: 5 and 32 and the V.sub.L sequence as set forth in the Sequence Listing as SEQ ID NOS: 6 and 33. 9. A method of claim 1 wherein said detection antibody, designated 5109, has the V.sub.H sequence as set forth in the Sequence Listing as SEQ ID NOS: 10 and 48 and the V.sub.L sequence as set forth in the Sequence Listing as SEQ ID NOS: 11 and 49. 10. An antibody of claim 1 which is labeled to facilitate detection. 11. An antibody of claim 10 wherein said label is radioactive, optical, enzymatic, fluorescent polarizing or fluorescent quenching. 12. An antibody of claim 1 which is labeled to facilitate capture of said antibody. 13. An antibody of claim 12 wherein said label is biotin or magnetic particles. 14. A method for monitoring biological media for protein fragments which comprises; contacting said biological media with an antibody active against the sequences set forth in the Sequence Listing as SEQ ID NOS: 3 and 4; and detecting the amount of protein fragments bound to said antibody. 15. A method of claim 14 wherein said protein fragments are collagen fragments. 16. A method of claim 14 wherein said antibody is a monoclonal antibody. 17. A method of claim 14 wherein said antibody is a genetically engineered antibody. 18. A method of claim 14 wherein said antibody, designated 5109, has the V.sub.H sequence as set forth in the Sequence Listing as SEQ ID NOS: 10 and 48 and the V.sub.L sequence as set forth in the Sequence Listing as SEQ ID NOS: 11 and 49. 19. The antibody, designated 9A4, having the V.sub.H sequence as set forth in the Sequence Listing as SEQ ID NOS: 5 and 32 and the V.sub.L sequence as set forth in the Sequence Listing as SEQ ID NOS: 6 and 33. 20. The antibody, designated 5109, having the V.sub.H sequence as set forth in the Sequence Listing as SEQ ID NOS: 10 and 48 and the V.sub.L sequence as set forth in the Sequence Listing as SEQ ID NOS: 11 and 49. 21. A cell line that produces a specific binding partner that binds to peptides consisting essentially of the structures as set forth in the Sequence Listing as SEQ ID NOS: 1 or 2 wherein the cell line is ATCC HB-12436. 22. A cell line that produces a specific binding partner that binds to peptides consisting essentially of the structures as set forth in the Sequence Listing as SEQ ID NOS: 3 or 4 wherein the cell line is ATCC HB-12435. 23. A genetically engineered form of antibody 9A4 such as that expressed by E. coli p9A4ICAT7-1 or p9A4IF-5 deposited as ATCC-98593 and ATCC-98592, respectively. 24. A genetically engineered form of antibody 5109 such as that derived from E. coli p5109CscFv7, which may be substituted for 5109 deposited as ATCC-98594.

Details for Patent 6,030,792

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2017-11-13