OBJECTIVE PF-06438179/GP1111 (PF-SZ-IFX) is an infliximab biosimilar. We evaluated the extended in-use physicochemical and biological stability of PF-SZ-IFX upon preparation for intravenous infusion. METHODS Two batches of PF-SZ-IFX were reconstituted to a concentration of 10 mg/mL and subsequently diluted to 0.4 and 4.0 mg/mL, representing the clinically relevant range for intravenous infusion. Dilution was performed in polyethylene saline infusion bags, which are commonly used in clinical practice. To simulate product handling under worst-case conditions, reconstituted solutions were stored for up to 30 days at 5 ± 3 °C and up to 14 days at 25 ± 2 °C (60 ± 5% relative humidity); diluted solutions were stored for up to 30 days under the same sets of conditions. Physicochemical and biological stability were evaluated according to pH, osmolality, appearance, particulate content, protein concentration, proportions of molecular weight variants and charge variants and potency. Standard and state-of-the-art analytical techniques were employed, including imaged isoelectric focusing, size exclusion chromatography, reducing sodium dodecyl sulphate capillary electrophoresis and functional cell-based bioassay. RESULTS Across batches and concentrations of PF-SZ-IFX, all parameters resided within the predefined acceptance criteria, including pH, osmolality, particulate content, clarity, protein concentration, molecular weight variants, charge variants and potency, for up to 30 days under both storage conditions tested (up to 14 days for reconstituted samples stored at 25 ± 2 °C). CONCLUSIONS Physicochemical and biological analyses demonstrated that the infliximab biosimilar PF-SZ-IFX was not affected by extended storage of the diluted preparations used for intravenous infusion.

中文翻译：

---

在准备静脉输注后，评估英夫利昔单抗生物仿制药PF-06438179 / GP1111的扩展使用稳定​​性。

目标PF-06438179 / GP1111（PF-SZ-IFX）是英夫利昔单抗生物仿制药。我们在准备静脉输注时评估了PF-SZ-IFX在使用中的扩展理化和生物稳定性。方法将两批PF-SZ-IFX复溶至10 mg / mL的浓度，然后分别稀释至0.4和4.0 mg / mL，代表临床上可用于静脉输注的范围。在临床实践中常用的聚乙烯盐水输注袋中进行稀释。为了模拟在最坏情况下的产品处理，重新配制的溶液在5±3°C下最多可保存30天，在25±2°C（60±5％相对湿度）下最多可保存14天。稀释的溶液在相同的条件下最多可保存30天。根据pH值，重量克分子渗透压浓度，外观，颗粒含量，蛋白质浓度，分子量变异体和电荷变异体的比例以及效价。采用了标准和最新的分析技术，包括成像等电聚焦，尺寸排阻色谱，还原十二烷基硫酸钠毛细管电泳和基于功能细胞的生物测定。结果在PF-SZ-IFX的不同批次和浓度下，所有参数均在预定义的接受标准内，包括pH，重量克分子渗透压浓度，颗粒浓度，净度，蛋白质浓度，分子量变异，电荷变异和效力，在两个条件下长达30天测试了储存条件（对于在25±2°C下储存的重构样品，最长可保存14天）。