Quartz crystal microbalance as a predictive tool for drug-material of construction interactions in intravenous protein drug administration

As a growing number of protein drug products are developed, formulation characterization is becoming important. An IgG product tested at concentrations from 0.0001 mg/mL - 0.1 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 antibody interaction during IV administration polymeric within syringes, lines, bags. Drug was characterized excipients, focus on surfactant. solutions were run over polymer-coated sensors measure the emphasis each formulation's components. Over 60 sensorgram data sets correlated assayed solution mock NS-diluted infusions equivalent QCM experiments build preliminary predictive model determining fraction surfactant adsorbed lost hydrophobic surface administration. These results create method reliably predictively estimating dose loss polymers different concentrations.