Analysis of the formation of (sub)visual particles in ready-to-administer trastuzumab infusion bags during transport from the hospital pharmacy to patients at home

For biological drugs, subvisible particle formation can cause loss of efficacy of the drug or trigger immune reactions. Transport of ready-to-administer infusion bags, to enable home treatment of cancer patients, might cause particle formation. The primary aim of this observational prospective pharmaceutical study is to investigate the effect of transport by car on the formation of subvisible particles in ready-to-administer infusion bags with trastuzumab. Hereto, trastuzumab was compounded (n = 19 infusion bags) in the hospital pharmacy and transported by car to patients' homes and thereafter to the laboratory for analysis. The analysis comprised visual inspection and qualitative and quantitative analyses of particle formation. The key findings revealed no significant difference in amount of particles between transported and non-transported bags based on the FlowCam, nanoparticle and HP-SEC analyses. Light obscuration revealed a statistically significant lower amount of particles ≥10 μm in non-transported samples, although absolute numbers of these particles was low. Transporting reconstituted trastuzumab infusion bags by car does not lead to a significant increase in the amount of aggregates in the infusion bags. Therefore, with regards to particle formation, home treatment of patients with trastuzumab was safe.