Resumen de Study of biological activity of infliximab
T. Álvarez Martín, M. Dolores Bellés Medall, Belén Montañés Pauls, M. Mendoza Aguilera, Celia Raga Jiménez, Carla Liñana Granell, Raúl Ferrando Piqueres
Purpose: To evaluate the biological stability of different concentrations of Inflectra® biosimilar and the reference product Remicade® processed and preserved according to standard clinical practice for 72 h. Method: Remicade® and Inflectra® were analyzed using Euroimmun I-2p® and reagents Lisa Tracker® by ELISA capture technique. Remicade® and Inflectra® biological stability was assayed for four concentrations (0.5 mg/mL, 1.2 mg/mL, 2.3 mg/mL and 10 mg/mL), conserved between 4-8°C and protected from light at time 0, 24, 48 and 72 h. Anti-TNF-a biological activity was considered stable when loss of concentration did not exceed 10% of the concentration at time 0. Results: None of the mixtures of Remicade® and of Inflectra® prepared showed a decrease of more than 10% of concentration at 24,48 and 72 h in comparison to the concentration at time 0. Conclusions: Remicade® and Inflectra® at concentrations of 0.5 mg/mL, 1.2 mg/mL, 2.3 and 10 mg/mL remain stable for at least 72 h when stored at 4-8°C and protected from light. The results obtained allow for an elevated optimization of costs
