Abstract

Polyvinyl chloride (PVC) is widely used in intravenous infusion systems due to its low cost and flexibility. Interactions between protein/peptide therapeutics and PVC surfaces pose a significant threat to drug stability and clinical efficacy. Quantitative studies show that monoclonal antibody mAb3 exhibits a 13.5% increase in protein aggregates after 1 hour of contact with PVC infusion bags. Intravenous immunoglobulin (IVIG) exposed to di(2-ethylhexyl) phthalate (DEHP)-plasticized PVC bags demonstrated a dramatic increase in particle concentration from 2,300 ± 440 to 96,000 ± 28,000 particles/ml, a change reported to correlate with increased immunogenic risk. Insulin solutions showed up to 40% initial dose loss due to surface adsorption, and IVIG monomer content dropped to 0.25 ± 0.03 mg/ml in the presence of DEHP, observed alongside a 4.69-fold increase in complement activation. Protein adsorption values on uncoated PVC reached 3.85 μg/cm², significantly higher than coated variants. These findings highlight hydrophobic and electrostatic interactions as key contributors to protein destabilization. Mitigation strategies such as surfactant addition and advanced coatings have shown potential to reduce protein loss by up to 60%–80%, yet limitations persist. This review emphasizes the urgent need for risk-based design of delivery systems to maintain protein drug efficacy, reduce the likelihood of immune responses, and improve patient safety in clinical applications.

Key words: PVC, therapeutic proteins, protein aggregation, adsorption, pharmaceutical stability