Advancing Autoinjector Innovation from Vision to Industry Impact

A pharmaceutical company approached DALIMED to develop a delivery solution for Lanreotide product. The customer required an injection device that could fit the extreme viscosity of the drug, achieve minimum dead volume, a passive safety mechanism, and a targeted needle concealment. DALIMED’s SAN-LIGHT passive safety needle met the baseline requirements for sharps protection and needle concealment. However, due to the extreme viscosity, the dead-volume constraints, and deep-SC injection profile of the drug, the device required significant customization to function as a viable delivery system.

Lanreotide (the active ingredient in Somatuline®) is a long-acting somatostatin analogue used to treat acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Administered via deep-subcutaneous (deep-SC) injection in 60 mg, 90 mg, and 120 mg strengths, the drug represents a significant and growing global market for generic alternatives. The formulation is a highly viscous, gel-like depot. It requires a slow manual injection of approximately 20 seconds, posing a severe engineering challenge for the delivery device.

To meet the precise demands of the Lanreotide drug, DALIMED executed a series of engineering modifications:

• Needle Configuration Upgrade
Moving from a standard SAN-LIGHT configuration of 27G × 8mm needle to an 18G × 20mm needle enabling deep-SC injection of the highly viscous drug.
• Device Structure and Geometry
To accommodate the longer and wider needle, the overall device length, front-end geometry, and internal architecture were enlarged. Despite the increased size, the goal was to keep the device ergonomic and user-friendly, The entire product was scaled to facilitate the new needle size while maintaining the basic SAN-Light’s intuitive operation and reliable passive shielding post-injection.
• Custom Interface and Minimum Dead Volume
Because the drug is costly and administered in small volumes, minimizing dead volume was critical. DALIMED replaced the standard Luer-lock connection with a newly developed, non-standard connection and a customized matching cap, specifically engineered to achieve minimum dead volume (minimum waste) at the syringe-to-needle connection.

The final product was tailored to distinct market expectations regarding needle visibility. In Europe, where the injection is primarily HCP-administered, with limited/conditional home use, the device was configured with the needle tip slightly exposed prior to injection to enable the user to see the penetration point. In the U.S., administration involves HCPs, caregivers, and end users, the preferences are for complete needle concealment. DALIMED adapted the device to fully hide the needleuse for the U.S. market, maintaining the exact same intuitive handling and passive safety principles across both configurations.

Because the customized device was paired with a generic drug, the project required strict regulatory alignment. In the U.S., it followed the NDA 505(b)(2) pathway as a combination product. In Europe, the device required CE marking to support the drug’s marketing authorization. DALIMED supported this process by executing the required functional and safety testing, compiling technical files, and preparing the rigorous documentation for these regulatory submissions. Furthermore, DALIMED prepared everything required for mass production, developing the molds and tooling, and setting up the full production line to ensure the customized device was completely ready for commercial scale.