Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17

Abstract

when stored at low temperature (5 °C) or room temperature (25 °C) with 60% relative humidity for up to 28 days. Results: Multiple orthogonal and complementary tests demonstrated that CT-P17 was stable for 28 days under all tested conditions, as well as for protein concentrations tested (50 vs 100 mg/mL), type of delivery device (autoinjector vs prefilled syringe), and manufacturing date (recently manufactured vs aged for 17 months). There were slight differences among products in terms of charge variants, oxidation level, purity, and number of subvisible particles; however, overall, the quality of each product was maintained over 28 days. Conclusion: Our data suggest that CT-P17 may be used without any significant loss of stability when stored at 5 °C or 25 °C with 60% relative humidity for up to 28 days, and was not impacted by protein concentration tested and delivery device. Comparative stability data suggest that the appropriate maximum storage period for CT-P17 may be up to 28 days at room temperature with 60% relative humidity.

Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review

“…Under normal circumstances, ADL must be refrigerated (2 °–8 °C [36 °–46 °F]); however, if needed (e.g., when traveling), ADL may be stored under alternative conditions (Table 3 ) [ 2 , 33 – 41 ]. All ADL products can be stored at 25 °C (77 °F) with storage durations ranging from 14 to 31 days (Table 3 ), as determined from stability studies and specified in the product labelling instructions [ 2 , 33 – 41 , 95 , 96 ]. One ADL biosimilar, Abrilada (adalimumab-afzb), may be stored at temperatures of up to 30 °C (86 °F) for 30 days [ 33 ].…”