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Manuela Velázquez Prieto
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Volume 19 - Issue 6, November-December 2017
ORIGINAL
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



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