Stability of therapeutic monoclonal antibodies during infusion with elastomeric pumps intended for home-based therapy.

The majority of monoclonal antibodies (mAbs) are administered through intravenous infusion, typically in hospitals. A shift towards home-based therapy, initially driven by the COVID-19 pandemic, has been underway in recent years. Elastomeric pumps are devices that can be used for home-based therapy. They have been used for analgesics and antibiotics but not for delicate APIs such as proteins. While there is interest in using elastomeric pumps for administration of mAbs, and a few reports indicate that some hospitals have already started using them, valid stability data are lacking. This study aimed to investigate the stability of two marketed antibodies, Erbitux (cetuximab) and Herzuma (trastuzumab), during infusion using an elastomeric pump. High-performance size exclusion chromatography (HPSEC), flow imaging microscopy (FIM), dynamic light scattering (DLS), UV-VIS spectroscopy, and nanoparticle tracking analysis (NTA) were employed to assess subvisible particles and aggregation. Results show high stability and no degradation in form of aggregation in HPSEC. FIM data revealed that particle counts were the same before and after infusion using the pump. DLS and NTA data exhibited uniform particle sizes across samples, suggesting undetectable aggregation. Overall, findings support the technical feasibility of utilizing this combination of elastomeric pump and conditions for administration of cetuximab and trastuzumab, providing valuable insights into maintaining product stability outside traditional healthcare settings.