Key Considerations When Transitioning From A Vial To A Pre-Filled Syringe Or A Cartridge In An Auto-Injector Device

By Jo Anne Jacobs, INCOG BioPharma Services

The growth in the number and types of biologic therapeutics has led to increased interest in self-administration of these products. Prefilled syringes, autoinjectors, pens, and wearable pumps are becoming more prevalent. Migrating an existing product from a vial presentation to a syringe or cartridge presentation offers several advantages. These include ease of administration, improved safety, and reduced risk of contamination. Long term, they may also lead to cost savings. The overall cost of the syringe configuration may be higher, but the decrease in waste and increase in patient compliance can offset this cost.

This article walks through:

• How does the formulation team approach the transition?
• What compatibility testing is needed? 
• What stresses will the bulk product undergo during formulation, filtration, and filling into the cartridge or syringe?