Human anti-Rh (D) monoclonal antibodies

Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Monoclonal antibody or fragment thereof

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5303581, 53038825, 4241411, 4241301, 4241561, A61K 39395, C12N 512

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active

056653565

ABSTRACT:
The present invention provides human monoclonal antibodies having the following essential characteristics: (a) binding to Rh(D) antigen, but not C, c, E or e antigens of the Rh blood group system; (b) being IgG1 proteins; (c) having kappa light chains; (d) being Glm(3) or Glm(1,17) allotype; (e) binding to D.sup.u cells by an indirect antiglobulin test; (f) binding to D.sup.IV, D.sup.V and D.sup.VII variant antigens; and (g) not binding to D.sup.VI or D.sup.B variant antigens, which may be employed for Rh-typing of red blood cells and passive immunization to prevent hemolytic disease of the newborn. Such a monoclonal antibody is exemplified by the monoclonal antibodies of cell lines ECACC 87091605 and 87091604 deposited at the European Collection of Animal Cell Cultures, Public Health Laboratory Service Center for Applied Microbiology and Research, Porton Down, Salisbury, Wiltshire, SP4, OJG, England on Sep. 16, 1987.

REFERENCES:
Bron et al., "Production of Human Monoclonal IgG Antibodies Against Rhesus (D) Antigen", Proc. Natl. Acad. Sci. USA, 81:3214-3217 (1984).
Crawford et al., "Production of Human Monoclonal Antibody to Rhesus D Antigen", The Lancet, 386-388 (1983).
Doyle et al., "In Vitro Development of Human Monoclonal Antibody-Secreting Plasmacytomas", Human Immunology 13:199-209 (1985).
Kumpel et al., "Heterogeneity in the Ability of IgG1 Monoclonal Anti-D to Promote Lymphocyte-Mediated Red Cell Lysis", Eur. J. Immunol. 19:2283-2288 (1989).
Kumpel et al., "Human Monoclonal Anti-D Antibodies I. Their Production, Serology, Quantitation and Potential Use as Blood Grouping Reagents", British J. Haemotology 71:125-129 (1989).
Kumpel et al., "Human Monoclonal Anti-D Antibodies II. The Relationship between IgG Subclass, Gm Allotype and Fc Mediated Function", British J. Haemotology 71:415-420 (1989).
Leader et al., "Human Monoclonal Anti-D with Reactivity Against Category D.sup.VI Cells Used in Blood Grouping and Determination of the Incidence of the Category D.sup.VI Phenotype in the D.sup.U Population", Vox. Sang. 58:106-111 (1990).
Lomas et al., "Tar + Individuals With Anti-D, A New Category D", Transfusion, 26(6):S62 (1986).
Lomas et al., "Demonstration of Seven Epitopes on the Rh Antigen D Using Human Monoclonal Anti-D Antibodies and Red Cells from D Categories", Vox. Sang. 57:261-264 (1989).
Lowe et al., "A Human-Human Monoclonal Anti-D by Direct Fusion with a Lymphoblastoid Line" Vox Sang., 51:212-216 (1986).
MacDonald et al, "Production and Characterization of Human-Human and Human-Mouse Hybridomas Secreting Rh(D)-Specific Monoclonal Antibodies" Scand. J. Immun., 25:477-483 (1987).
McCann et al., "Production and Use of Human Monoclonal Anti-D Antibodies", Journal of Immunological Methods, 115(1):3-15 (1988).
Melamed et al., "Requirements for the Establishment of Heterohybridomas Secreting Monoclonal Human Antibody to Rhesus (D) Blood Group Antigen", Journal of Immunological Methods, 104:245-251 (1987).
Mollison et al., Chapter 2 of Haemolytic Disease of the Newborn, ed. G. Garraty, 1-32 (1984).
Ono et al., "Preparation of Monoclonal Antibody to Rh(D)-Positive Antigen", Chemical Abstract No. 147012e, vol. 104, No. 17 (28 Apr. 1986) (English abstract of JP 60-136599).
Paire et al., "Establishment of Human Cell Lines Producing Anti-D Monoclonal Antibodies: Identification of Rhesus D Antigen", Immunol. Lett., 13:137-141 (1986).
Thompson et al., "Production of Human Monoclonal IgG and IgM Antibodies With Anti-D(rhesus) Specificity Using Heterohybridomas", Immunology, 58:157-160 (1986).
Thomson et al., "Clearance of Rh D-Positive Red Cells With Monoclonal Anti-D", The Lancet, 336:1147-1150 (1990).
Tippett, "Sub-Divisions of the Rh (D) Antigen", Medical Laboratory Science, 45:88-93 (1988).
Tippett et al., "Observations on Subdivisions of the Rh Antigen D", Vox Sang., 7:9-13 (1962).

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