Human anti-Rh(D) monoclonal antibodies and methods of use of ant

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

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4241531, 53038815, 5303887, A61K 39395, C07K 1634, C12N 522

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active

056539789

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 IgG3 proteins; (c) having kappa light chains; (d) being of the allotype G3m(21); (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 antibody of cell line ECACC 87091606 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:
Bloy et al., "Human Monoclonal Antibody Against Rh(D) Antigen: Partial Characterization of the Rh(D) Polypeptide from Human Erythrocytes", Blood, 69(5):1491-1497 (1987).
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).
Foung et al, "Human Monoclonal Antibodies to Rh(D)",Vox Sang., 53:44-47 (1987).
Kornprobst et al., "Determination of Rh(D) Genotype: Use if Human Monoclonal Antibodies in Flow Cytometry", J. Clin. Pathol., 39:1039-1042 (1986).
Lomas et al., "Tar + Individuals With Anti-D by Direct Fusion A New Category D"; Tranfusion; 26(6): S62 (1986).
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 Human Monoclonal Anti-D Antibodies", Journal of Immunological Methods, 115(1):3-15 (1988).
Mollison et al., Chapter 2 of Haemolytic Disease of the Newborn, ed. G. Garraty, 1-32 (1984).
Paire et al., "Establishment of Human Cell Lines Producing Anti-D Monoclonal Antibodies: Indentification of Rhesus D Antigen",Immunol. Lett., 13:137-141 (1986).
Thompson et al., "Production of Human Monoclonal IgG and IMG Antibodies With Anti-D(rhesus) Specificity Using Heterohybridomas", Immunology, 58:157-160 (1986).
Thompson et al., "The Efficient Production of Stable, Human Monoclonal Antibody-Secreting Hybridomas from EBV-transformed Lymphocytes Using the Mouse Myeloma X63-Ag8.653 as a Fusion Partner", J. Immunol. Meth., 94:7-12 (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 if the Rh Antigen D", Vox Sang., 7:9-13 (1962).

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