Application of a Caprylate/Chromatography Purification Process for Production of a Hepatitis B Immune Globulin from Pooled Human Plasma

IF 0.5 Q4 HEMATOLOGY Plasmatology Pub Date : 2023-01-01 DOI:10.1177/26348535221131252
Jyoti Srivastava, Chad Talton, Pete Vandeberg, Michelle Woznichak, W. Keither Merritt, Marta Jose
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Abstract

Background Hepatitis B (HB) is a worldwide public health problem affecting around 250 million people. Only about 10% of people with HB are aware that they are infected. Vaccination is crucial to prophylactically controlling HB and the combination of vaccination and HB immune globulin (HBIG) are essential in preventing disease after exposure to the HB virus. Objectives In this article, a caprylate-chromatography process has been used for the production of HBIG (HBIG-C). The previously used solvent-detergent process produced an HBIG (HBIG-S/D) with an excellent safety profile but allowed the retention of some procoagulant plasma proteins. The present studies were conducted to assess the character and purity of HBIG produced by the caprylate-chromatography process. Design and Methods Several analytical methods (eg, chromatography, immunoassays, and nephelometry) were used to assess the molecular characteristics, purity and HBIG potency and specific activity of HBIG-C. In addition, testing was conducted to assess the levels of several pro-coagulant factors. HBIG-C was compared with HBIG-S/D and other immunoglobulins manufactured by the S/D process. Results The analysis of HBIG-C showed that the product was almost entirely IgG (99.3 ± 0.2% by electrophoresis) and that the residual IgA was less than that found in S/D products. The IgG present in HBIG-C was 99.7 ± 0.6% monomers and dimers as measured by size exclusion chromatography. Aggregates and fragments constituted < 1%. The IgG subclass distribution in HBIG-C was in the normal reference range. Coagulation factor impurities and pro-coagulant activity were reduced in HBIG-C compared to IgG prepared by the S/D method. Conclusions HBIG-C takes advantage of long-established donor selection processes combined with recently improved manufacturing processes to produce a safe and effective HBIG-product. HBIG-C combines high purity with reduced pro-coagulant factors in a product used for post-exposure prophylaxis of HB.
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辛酸盐/层析纯化工艺在人血浆中制备乙型肝炎免疫球蛋白中的应用
乙型肝炎(HB)是一个全球性的公共卫生问题,影响着约2.5亿人。只有大约10%的HB患者知道自己被感染了。疫苗接种对于预防控制HB至关重要,疫苗接种和HB免疫球蛋白(HBIG)的结合对于预防暴露于HB病毒后的疾病至关重要。目的采用辛酸色谱法制备HBIG (HBIG- c)。以前使用的溶剂-洗涤剂工艺生产的HBIG (HBIG- s /D)具有良好的安全性,但允许保留一些促凝血浆蛋白。本研究对辛酸色谱法制备的HBIG的性质和纯度进行了评价。设计与方法采用色谱法、免疫分析法、比浊法等多种分析方法评价HBIG- c的分子特性、纯度、HBIG效价和比活性。此外,还进行了测试以评估几种促凝因子的水平。将HBIG-C与HBIG-S/D及S/D法生产的其他免疫球蛋白进行比较。结果HBIG-C分析显示,产物几乎全部为IgG(电泳为99.3±0.2%),残留IgA少于S/D产物。大小排斥色谱法测定HBIG-C中IgG的单体和二聚体含量为99.7±0.6%。聚集体和碎片构成<1%。HBIG-C中IgG亚类分布在正常参考范围内。与S/D法制备的IgG相比,HBIG-C中的凝血因子杂质和促凝活性降低。结论:HBIG-C利用长期建立的供体选择过程,结合最近改进的制造工艺,生产出安全有效的hbig产品。HBIG-C结合了高纯度和减少的促凝因子,用于乙肝暴露后预防的产品。
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Plasmatology
Plasmatology HEMATOLOGY-
CiteScore
1.10
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