Grifols Bioscience Research Group; Biomat USA, Inc., Research Triangle Park, NC, 27709, USA.
Sci Rep. 2020 Apr 22;10(1):6850. doi: 10.1038/s41598-020-63794-y.
Human-plasma-derived immune globulin (IG) is used in augmentation therapy to provide protective levels of antibodies to patients with primary immune deficiency diseases (PIDD) and for prophylaxis against infectious diseases. To maintain the breadth of antibodies necessary for clinical protection, it is important to understand regional patterns of antibody seroprevalence in source plasma from which IG products are manufactured. In this study, source plasma from donation centers in various locations of the Southwestern quarter of the United States was surveyed for antibody titers to hepatitis A virus (HAV), measles virus (MeV), and cytomegalovirus (CMV). A broad range of anti-HAV Ig plasma titers was observed among these centers, with some centers exhibiting 3-5 times the titers of the others. Minor to no differences were observed for levels of anti-MeV and anti-CMV, respectively. Importantly, elevated anti-HAV Ig titers were broadly observed across plasma units obtained from the centers exhibiting high titers, indicative of a potential regional phenomenon among donors as opposed to few donors with singularly high titers. Plasma from these high-titer centers conferred significantly greater neutralization against HAV in vitro. The outcomes of this study give a glimpse of the antibody diversity inherent in human plasma used to manufacture IG products..
人血浆来源的免疫球蛋白 (IG) 被用于增强治疗,为原发性免疫缺陷病 (PIDD) 患者提供保护性抗体水平,并预防传染病。为了保持用于临床保护的抗体广度,了解用于制造 IG 产品的源血浆中抗体血清流行率的区域模式很重要。在这项研究中,调查了美国西南部各个地点的献血中心的源血浆中针对甲型肝炎病毒 (HAV)、麻疹病毒 (MeV) 和巨细胞病毒 (CMV) 的抗体滴度。观察到这些中心的抗 HAV Ig 血浆滴度范围很广,有些中心的滴度是其他中心的 3-5 倍。抗 MeV 和抗 CMV 的水平分别观察到较小的差异。重要的是,在表现出高滴度的中心获得的血浆单位中广泛观察到升高的抗 HAV Ig 滴度,这表明供体之间存在潜在的区域性现象,而不是少数供体具有单一的高滴度。来自这些高滴度中心的血浆在体外对 HAV 具有显著更高的中和能力。这项研究的结果揭示了用于制造 IG 产品的人血浆中固有的抗体多样性。