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Endotoxin level < 0.01EU/µg by LAL method
Use a manual defrost freezer and avoid repeated freeze thaw cycles. Store at 2 to 8 °C for one week. Store at -20 to -80 °C for twelve months from the date of receipt.
Roledumab is a biosimilar that targets RHD. The Rhesus (Rh) blood group system represents one of the most complex and important systems in humans. Two highly homologous genes RHD and RHCE (collectively referred to as RH30 or RHCED) encode the antigens of the Rh blood group system (1-4). These tightly linked genes map to human chromosomal position 1p34.1-1p36. The RHD gene, which is commonly deleted from a large segment of the population, encodes the most potent blood group immunogen, the D antigen (2,5). Rh incompatibility between maternal and fetal blood types results in hemolytic disease of the newborn (HDN), which often results in fetal death (1,2,6). The RHCE gene exists in four allelic forms, and each allele determines the expression of two antigens in Ce, ce, cE, or CE combinations (2,4,5). The RHCED antigens exist as integral membrane proteins with contain 12-transmembrane helices, and maintain erythrocyte membrane integrity. The presentation of the Rh antigenic activity requires the formation of a complex between the RHCED antigens and RHAG (RH50).
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