|Former: Atención Farmacéutica|
|Journal edited by Rasgo Editorial since 1983|
Manuela Velázquez Prieto
EDITOR IN CHIEF
Jaime E. Poquet Jornet
Tomás Casasín Edo
Virginia Hernández Corredoira
Ramón Jódar Masanés
Juan Carlos Juárez Giménez
Volume 19 - Issue 6, November-December 2017
STUDY OF BIOLOGICAL ACTIVITY OF INFLIXIMAB
ÁLVAREZ MARTÍN TAMARA, BELLES MEDALL LOLES, MONTAÑES PAULS BELÉN, MENDOZA AGUILERA MARÍA, RAGA JIMÉNEZ CELIA, LINANA GRANELL CARLA, FERRANDO PIQUERES RAÚL
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 4-8ºC and protected from
light at time 0, 24, 48 and 72 h. Anti-TNF-ἁ 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 4-8ºC and protected from light. The results obtained allow for an elevated optimization of costs.
BIOLOGICAL ACTIVITY – EXTENDED STORAGE – INFLECTRA – INFLIXIMAB – REMICADE