Combination Product Development Considerations for Subcutaneous 2 mL Dose Delivery
Information
High dose biologic formulations are pushing drug volume and viscosity beyond traditional self-injection design space limits (> 15 cP, > 1 ml dose volume), which can challenge patients’ capabilities to administer their injections based on injection time or force.12
We will discuss how ergonomic, manual, syringe-based injections can enable subcutaneous self-injections with characteristics that go beyond the traditional boundaries of volume and viscosity. Important factors for the development of combination products involving delivery of higher volumes (1-2 mL) are presented, including assembly, human factors, documentation, and platform considerations.
