Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions

Study objectives: To investigate the quality and in-use stability of diluted ABP 980 (a trastuzumab biosimilar) versus reference trastuzumab to mimic dosing in intravenous (IV) bags, transportation and extended storage prior to infusion. Methods: Low dose (70 mg; 0.3 mg/mL) and high dose (1,200 mg; 3.8 mg/mL) ABP 980 and reference trastuzumab solutions were prepared, light-protected and subjected to transportation simulation and storage (2[degrees]C-8[degrees]C or 30[degrees]C for 5 weeks, followed by 48 hours at 30[degrees]C). Stability was assessed pre- and post-transport; at Weeks 1, 2, 4, and 5; at Week 5 after 48 hours at 30[degrees]C; and pre- and post-infusion using an infusion pump. Results: Across doses and temperatures, there was little change in high molecular weight species and no detectable loss in purity. Following storage, visible particles (> 125 [micro]m) were intermittently observed for both products, with increased subvisible particles detected with low doses. Extended storage at 2[degrees]C-8[degrees]C did not lead to any significant loss in the active molecule, with consistent biological potency across doses and temperatures for both products. Higher-dose dilutions maintained pH closer to the initial formulation specifications. Discussion: This study examined the impact of dilution, transport and extended storage at different temperatures on the stability of ABP 980 and reference trastuzumab. No major differences between the two products were observed. Conclusion: Across storage temperatures, multiple stability-indicating assays demonstrated no clinically meaningful impact to product quality and stability for both ABP 980 and reference trastuzumab, which provides assurance that ABP 980 retains stability and activity over extended storage periods. Keywords: ABP 980, biosimilar, stability, trastuzumab