Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, all antibody products shall meet the applicable requirements of this section.
Antibody. An immunoglobulin molecule, having a precise glycoprotein structure, produced by certain cells of the B lymphocyte lineage in response to antigenic stimulation, and functioning to specifically bind and influence the antigens that induced its synthesis.
IgG (Immunoglobulin G). One of the several recognized classes of structurally related glycoproteins whose representatives include all known antibodies.
Monoclonal. Produced by, or derived from, the offspring of a single common progenitor cell.
Failure of passive transfer. A condition of neonates characterized by an abnormally low concentration of circulating maternal IgG.
9 C.F.R. §113.450