Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Binds hormone or other secreted growth regulatory factor,...
Reexamination Certificate
2003-10-23
2009-02-03
O'Hara, Eileen B. (Department: 1644)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Binds hormone or other secreted growth regulatory factor,...
C424S133100, C424S177100, C530S387100
Reexamination Certificate
active
07485303
ABSTRACT:
The present invention is directed to a pharmaceutical composition comprising F(ab′)2antibody 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′)2antibody fragments using serum 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′)2fragments is free of albumin and complete antibodies, and substantially free of pyrogens.
REFERENCES:
patent: 4401663 (1983-08-01), Buckwalter et al.
patent: 4806346 (1989-02-01), Hum et al.
patent: 4814433 (1989-03-01), Fredrickson
patent: 4849352 (1989-07-01), Sullivan et al.
patent: 4940670 (1990-07-01), Rhodes
patent: 5328834 (1994-07-01), Ngo et al.
patent: 5443976 (1995-08-01), Carroll
patent: 5733742 (1998-03-01), Landon
patent: 5888511 (1999-03-01), Skurkovich et al.
patent: 5904922 (1999-05-01), Carroll
patent: 6333032 (2001-12-01), Skurkovich et al.
patent: 6448054 (2002-09-01), Poznansky et al.
patent: 6534059 (2003-03-01), Skurkovich et al.
patent: 6709655 (2004-03-01), López de Silanes et al.
patent: 2003/0049725 (2003-03-01), Heavner et al.
patent: 2003/0215448 (2003-11-01), Skurkovich et al.
patent: 2003/0223995 (2003-12-01), Skurkovich et al.
patent: 2003/0224005 (2003-12-01), Skurkovich et al.
patent: 2003/0228310 (2003-12-01), Skurkovich et al.
patent: 2004/0062768 (2004-04-01), Skurkovich et al.
patent: 2004/0086508 (2004-05-01), Skurkovich et al.
patent: 2002237586 (2002-09-01), None
patent: 0 068 592 (1983-01-01), None
patent: 0 089 710 (1983-09-01), None
patent: 2 106 183 (1997-11-01), None
patent: WO 92/22324 (1992-12-01), None
patent: WO 01/58469 (2001-08-01), None
Burton et al. Nature Immunology, 2004, vol. 5, No. 3, pp. 233-236.
Vanlandschool et al. J. General Virology, 1998, 79:1781-1791.
Harlow and Lane, 1988, Antibodies Lab. Manual p. 298-299, Cold Spring Harbor Lab.
Campbell, Monoclonal Antibody and Immunosuppressor Technology, Elsevier, 1991. vol. 23, p. 288-291.
Calderon-Aranda et al., Toxicon, vol. 37, p. 771-782, 1999.
Cain, B.S., et al., “The Physiologic Basis for Anticytokine Clinical Trails in the Treatment of Sepsis,”J. Am. Coll. Surg. 186:337-351, American College of Surgeons (1998).
Fekade, D., et al. , “Prevention of Jarisch-Herxheimer Reactions by Treatment with Antibodies Against Tumor Necrosis Factor a,”N. Engl. J. Med. 335:311-315, Massachusetts Medical Society (1996).
Fox, D.A., “Cytokine Blockade as a New Strategy to Treat Rheumatoid Arthritis,”Arch. Intem. Med. 160:437-444, American Medical Association (2000).
Krueger, J.G., “The immunologic basis for the treatment of psoriasis with new biologic agents,”J. Am. Acad. Dermatol. 46:1-23, Mosby (2002).
Lisman, K.A., et al., “Managing Heart Failure with Immunomodulatory Agents,”Cardiol. Clin. 19:617-625, W.B. Saunders Co. (2001).
Luger, T., “Treatment of immune-mediated skin disease: future perspectives,”Eur. J. Dermatol. 11:343-347, John Libbey Eurotext (2003), downloaded from: <http://www.john-libbey-eurotext.fr/en/revues/medecine/ejd/e-docs/00/01/88/A6/article.md>.
Martin, G.S., “Current Management Strategies for Severe Sepsis and Septic Shock,” Presented at Chest 2001: 67th Annual Scientific Assembly of the American College of Chest Physicians, Nov. 4-8, 2001, Philadelphia, PA.
Present, D.H., et al., “Infliximab for the Treatment of Fistulas in Patients with Crohn's Disease,”N. Engl. J. Med. 340:1398-1405, Massachusetts Medical Society (1999).
Qian, Y., et al., “Topical Soluble Tumor Necrosis Factor Receptor Type I Suppresses Ocular Chemokine Gene Expression and Rejection of Allogenic Corneal Transplants,”Arch. Ophthalmol. 118:1666-1671, American Medical Association (2000).
Stapczynski, J.S., “Shock, Septic,” Dire, D.J., et al., eds., eMedicine.com Inc., (2004), downloaded from: <http://emedicine.com/EMERG/topic533.htm>.
Torres, P.F., and Kijlstra, A., “The role of cytokines in corneal immunopathology,”Ocul. Immunol. Inflamm. 9:9-24, Swets & Zeitlinger (2001).
Zhu, S., et al., “Early Expression of Proinflammatory Cytokines Interleukin-1 and Tumor Nexrosis Factor-α after Corneal Transplantation,”J. Interferon. Cytokine. Res. 19:661-669, Mary Ann Lieberg, Inc. (1999).
Abstract of Dick, A.D., et al., “Neutralizing TNF-α Activity Modulates T-cell Phenotype and Function in Experimental Autoimmune Uveoretinitis,”J. Autoimmun. 11:255-264, Academic Press (1998), downloaded from: <http://80-www.elsevier.com/proxygw.wrtc.org/wps.find.journaldescription.cws—home/622856/description>.
English language translation of Secretaria de Salud, “Potency of Anti-Poison Sera,” inFarmacopea de los Estadog Unidos Mexicanos, vol. II, Secretaria de Salud, Mexico City, MX, pp. 1756-1757 (2000).
English language translation of Secretaria de Salud, “Pyrogen Tests,” in:Farmacopea de los Estados Unidos Mexicanos, vol. I, Secretaria de Salud, Mexico City, MX, pp. 334-335 (2000).
Calderon-Aranda, E.S., et al., “Neutralizing capacity of murine sera induced by different antigens of scorpoin venum,”Toxicon31:327-337, Pergamon Press Ltd. (1993).
Licea, A.F., et al., FAB fragments of the monoclonal antibody BCF2 are capable of neutralizing the whole venom from the scorpoinCentruroides noxiushoffman,Toxicon34:843-847, Pergamon Press Ltd. (1996).
Banks, N., “Synopses of North-American Invertebrates. IX. The Scorpoins, Solpugids, and Pedipalpi,”Am. Nat. 34:421-427, Ginn & Company, Publishers (1900).
Banks, N., “The Scorpoins of California,”Pomona College J. Entomol. 2:185-190, The Biological Department of Pomona College (1910).
Barona, J., et al., “Aspectos toxinológocos e immunoquímicos del veneno del escorpiónTityus pachyurusPocock de Colombia: capacidad neutralizante de antivenenos producidos en Latinoamérica, or in English: Toxicological and immunological aspects of scorpoin poison (Tytius pachyurus): neutralizing capacity of antipoisons produced in Latin America,”Biomédica24:42-49, Instituto Nacional de Salud (Mar. 2004).
Unverified English language translation of Barona, J., et al., “Toxicological and immunological aspects of scorpoin poison (Tytius pachyurus): neutralizing capacity of antipoisons produced in Latin America,”Biomédica24:42-49, Instituto Nacional de Salud (Mar. 2004).
Becerril, B., et al., “Cloning and characterization of cDNAs that code for Na+-channel-blocking toxins of the scorpoinCentruroides noxiusHoffman,”Gene128:165-171, Elsevier Science Publishers B.V. (1993).
Calderon-Aranda, E.S., et al., “Neutralizing Capacity of Murine Sera Induced by Different Antigens of Scorpoin Venom,”Toxicon31:327-337, Pergamon Press, Ltd. (1993).
Calderon-Aranda, E.S., et al., “The use of synthetic peptides can be a misleading approach to generate vaccines against scorpoin toxins,”Vaccine13:1198-1206, Elsevier Science, Ltd. (1995).
Couraud, F., et al., “Two Types of Scorpoin Toxin Receptor Sites, One Related to the Activation, the Other to the Inactivation of the Action Potential Sodium Channel,”Toxicon20:9-16, Pergamon Press, Ltd. (1982).
Curry, S.C., et al., “Envenomation by the Scorpoin Centruroides Sculturatus,”J. Toxicol.-Clin. Toxicol. 21:417-449, Marcel Dekker, Inc. (1983-1984).
Dehesa-Dávila, M. and Possani, L.D., “Scorpionism and Serotherapy in Mexico,”Toxicon32:1015-1018, Elsevier Science, Ltd. (1994).
Dehesa-Davila, M., et al., “Clinical Toxicology of Scorpoin Stings,” inHandbook of Clin
de Silanes Juan Lopez
Mancilla-Nava Rita G
Paniagua-Solis Jorge F
Instituto Bioclon, S.A. de C.V.
Kim Yunsoo
O'Hara Eileen B.
Sterne Kessler Goldstein & Fox P.L.L.C.
LandOfFree
Pharmaceutical composition of F(ab')2 antibody fragments does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Pharmaceutical composition of F(ab')2 antibody fragments, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pharmaceutical composition of F(ab')2 antibody fragments will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4082043