Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig

Objective: Autoinjectors are a convenient and efficient way to self-administer subcutaneous injections of biopharmaceuticals. Differences in device mechanical design can affect the autoinjector functionality and performance. This study investigates the performance differences of two single-spring-actuated autoinjectors. Methods: We compare the performance between Emgality (120 mg/mL) and Aimovig (140 mg/mL) autoinjector devices from an engineering point of view at two test conditions: room (25 C (Formula presented.)) and storage (5 C (Formula presented.)) temperatures. We employ a novel experimental procedure to simultaneously acquire the force and acoustic signals during operation, and high-speed imaging during the needle insertion and drug injection. Results: We perform 18 quantitative comparisons between Emgality and Aimovig, and we observe that 14 of these have statistically significant differences. For both test conditions, Emgality requires an 8 N activation force while Aimovig requires 14 N activation force, and the needle of Emgality has an insertion depth of 5 mm while Aimovig has an insertion depth of 7 mm. The injection speeds are significantly affected by temperature. Emgality has an injection speed of 0.40 mL/s and 0.28 mL/s at room and storage temperature condition, respectively; while Aimovig has an injection speed of 0.24 mL/s and 0.16 mL/s at those conditions. Lastly, confirmation “click” sound of Emgality occurs 0.75–1.53 s after dose completion, while in Aimovig, the confirmation “click” sound occurs 0.26-0.46 s before dose completion. Conclusions: This study revealed performance differences between Emgality and Aimovig autoinjector devices, despite the fact that the delivery principle of these single-spring-actuated autoinjectors are the same. These differences may result in different risk of intramuscular injection and premature device removal, both of which need to be further verified in clinical trials.