Janssen Pharmaceuticals, A Johnson & Johnson Company 1400 McKean Rd, Lower Gwynedd Township, PA 19002, USA.
Janssen Pharmaceuticals, A Johnson & Johnson Company 335 Phoenixville Pike, Malvern, PA 19355, USA.
J Pharm Sci. 2023 Dec;112(12):3154-3163. doi: 10.1016/j.xphs.2023.07.019. Epub 2023 Aug 18.
As a growing number of protein drug products are developed, formulation characterization is becoming important. An IgG drug product is tested at concentrations from 0.0001-0.1 mg/mL for adsorption behavior to polymer surfaces polyvinyl chloride (PVC) and polypropylene (PP) upon dilution in normal saline (NS) using quartz crystal microbalance with dissipation (QCM-D). The studies mimicked IgG antibody interaction during IV administration with polymeric surfaces within syringes, lines, and bags. Drug product was characterized with excipients, with focus on surfactant. Drug solutions were run over polymer-coated sensors to measure the adsorption behavior of the formulation with emphasis on the behavior of each of the formulation's components. Over 60 sensorgram data sets were correlated with assayed protein solution concentrations in mock NS-diluted infusions of drug product in the equivalent concentrations to QCM experiments to build a preliminary predictive model for determining fraction of drug and surfactant adsorbed and lost at the hydrophobic surface during administration. These results create a method for reliably and predictively estimating drug product adsorption behavior and protein drug dose loss on polymers at different protein drug concentrations.
随着越来越多的蛋白质药物产品的开发，制剂特征分析变得越来越重要。在正常盐水中（NS），使用石英晶体微天平（QCM-D）对聚氯乙烯（PVC）和聚丙烯（PP）聚合物表面的吸附行为进行测试，浓度范围从 0.0001-0.1mg/mL。这些研究模拟了 IgG 抗体在 IV 给药过程中与注射器、管路和袋子内的聚合物表面的相互作用。对药物产品的赋形剂进行了表征，重点是表面活性剂。药物溶液在聚合物涂层传感器上运行，以测量制剂的吸附行为，重点是制剂中每个成分的行为。将 60 多个传感器图谱数据集与模拟 NS 稀释的药物产品在 QCM 实验等效浓度下的蛋白溶液浓度相关联，以建立一个初步的预测模型，用于确定在给药过程中疏水表面上药物和表面活性剂的吸附和损失分数。这些结果为可靠地预测蛋白质药物产品在不同蛋白质药物浓度下在聚合物上的吸附行为和蛋白质药物剂量损失提供了一种方法。
