How Confident Are You In Your Autoinjector?

As demand for self-administered therapies accelerates, autoinjectors, formally known as automated needle-based injection systems (NIS-AUTO), are playing an increasingly central role in modern medicine. These devices offer convenience, improve adherence, and support patient autonomy, while also easing the burden on healthcare systems.

However, their dual role as both drug and device introduces a unique set of regulatory and performance challenges that must be addressed from early development through to commercialization. From regulatory hurdles to patient safety risks, overlooking critical aspects of combination product testing can lead to costly setbacks. Our white paper outlines the key considerations for autoinjector development and commercialization, including:

• Functional testing
• Extractables & leachables (E&L)
• Container closure integrity testing (CCIT)
• Stability studies