Multiple analytical and preclinical studies were performed to compare the biochemical characteristics, pharmacokinetics (PK), safety and neoantigenicity of a new 5% liquid formulation of Alpha-1 Proteinase Inhibitor (Liquid A1PI, Prolastin®-C Liquid) with the lyophilized version (Lyophilized A1PI, Prolastin®-C). Liquid A1PI and Lyophilized A1PI had similar average mass (~52 kDa), and both forms exhibited glycoform patterns consistent with the known banding pattern of A1PI (dominated by the M6 and M4 bands, including deconvoluted masses). Both Liquid A1PI and Lyophilized A1PI yielded average percent purity values ranging from 96% to 99% and had active content ranging from 53 mg/mL to 59 mg/mL. The PK profile of Liquid A1PI was similar to Lyophilized A1PI. Safety assessments in rabbits showed good tolerability and no test article-related changes in mortality, clinical signs, clinical pathology, body weight, food consumption, or urinalysis parameters. Following immunodepletion of antibodies that recognize Lyophilized A1PI, there were no significant differences in the anti-drug titers among animals immunized with Lyophilized A1PI and Liquid A1PI (p > 0.05), indicating that no antibodies to neoantigens were generated. Liquid A1PI and Lyophilized A1PI have similar profiles with respect to biochemical characteristics, PK, safety and neoantigenicity.

进行了多次分析和临床前研究，以比较新型5％Alpha-1蛋白酶抑制剂液体制剂（液体A1PI，Prolastin®-C液体）与冻干版本（冻干）的生化特性，药代动力学（PK），安全性和新抗原性。 A1PI，Prolastin®-C）。液体A1PI和冻干的A1PI具有相似的平均质量（〜52 kDa），并且两种形式均显示出与已知的A1PI谱带模式一致的糖型模式（以M6和M4谱带为主，包括去卷积质量）。液体A1PI和冻干的A1PI均产生的平均纯度百分比值介于96％至99％之间，且活性成分的范围介于53 mg / mL至59 mg / mL之间。液体A1PI的PK曲线类似于冻干的A1PI。在兔子中进行的安全性评估显示出良好的耐受性，并且在死亡率，临床体征，临床病理，体重，食物消耗或尿液分析参数方面没有与测试物品相关的变化。对识别冻干的A1PI的抗体进行免疫耗竭后，用冻干的A1PI和液体A1PI免疫的动物之间的抗药物效价没有显着差异（p  > 0.05），表明未产生针对新抗原的抗体。液体A1PI和冻干的A1PI在生化特性，PK，安全性和新抗原性方面具有相似的特征。