TY - JOUR T1 - Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials JF - European Journal of Hospital Pharmacy JO - Eur J Hosp Pharm DO - 10.1136/ejhpharm-2021-003198 SP - ejhpharm-2021-003198 AU - Mona Abdel-Tawab AU - Markus Waßmuth AU - Florian Gegenfurtner AU - Andrea Hawe AU - Jan H Schefe AU - Anke M Strunz AU - Joachim Wübert Y1 - 2022/07/19 UR - http://ejhp.bmj.com/content/early/2022/07/26/ejhpharm-2021-003198.abstract N2 - Objectives Aggregation is one of the key critical points limiting the stability of monoclonal antibodies in solution. The present study aimed to investigate the in-use stability of a residual monoclonal antibody solution after withdrawal of most of the filling volume of PF-06439535 (bevacizumab biosimilar), addressing the physical and chemical stability with respect to aggregation and fragmentation.Methods The stability of residual PF-06439535 solution (25 mg/mL) after withdrawal of 80% (12.8 mL) filling volume with a 20G needle was monitored over a light-protected storage period of 8 days at 2–8°C and 25°C with measurement time points at D0 (start of storage), D2, D4, and D8 (2, 4, and 8 days of storage after start, respectively). Unopened vials stored under the same conditions served as control. For this purpose, the analytical results from size exclusion chromatography, dynamic light scattering, and micro-flow imaging obtained after the individual measurement time points up to 8 days were compared with those obtained at D0 and with those obtained for unopened vials stored under the same conditions.Results No aggregation or ongoing fragmentation due to partial withdrawal of filling volume could be observed in the residual PF-06439535 solution. Moreover, no changes in the particle size distribution at D8 compared with the D0 values were identified upon storage at either 2–8°C or 25°C (both opened and unopened vials). The total concentration of particles ≥10 µm of all samples was <100 particles/mL. In addition, no variations in the pH values or in the visual appearance were detected over the whole study period in all samples at all storage conditions.Conclusions Consequently, residual PF-06439535 solution (25 mg/mL) in opened vials may be regarded as stable when stored light-protected over a period of 8 days in the refrigerator (2–8°C) or at 25°C. ER -