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血浆衍生的因子Ⅷ浓制剂,其生产涉及提纯和病毒灭活方法。这些有可能改变因子Ⅷ分子的免疫源性,因此有增加病人抑制剂形成的危险。CSL生产一种纯浓制剂抗血友病球蛋白[AHF(High Purity)],有关其在病人形成抑制剂方面有极佳临床记录,而且现已发展成一种新的高纯因子Ⅷ浓制剂——Biostate。当与无免疫源的AHF(High Purity)比较时必须证实Biostate中的因子Ⅷ是完整的,以保证改良生产过程而未改变其免疫源性。 评价Biostate新抗原的产生已进行体内外试验。
Plasma-derived factor VIII concentrates, whose production involves purification and virus inactivation methods. These are likely to alter the immunogenicity of Factor VIII molecules and therefore increase the risk of patient inhibitor formation. CSL produces a pure concentrate of anti-hemophilia globulin [AHF (High Purity)] for its excellent clinical record in the formation of inhibitors in patients and has since evolved into a new class of high-purity factor VIII concentrates - -Biostate. When compared to AHF (High Purity) without immune source, Factor VIII in Biostate must be verified to ensure improved production without compromising immunogenicity. Evaluation of Biostate Neogen Antigen Production In vitro and in vivo assays have been performed.