Formulation & Device Considerations for Subcutaneous (SC) Delivery of Biotherapeutics

• Overview of subcutaneous delivery in the current market
• Considerations when developing a target product profile for subcutaneous delivery
• Identifying early challenges and opportunities in formulation and device development
• Technology down selection and moving forward towards the target image

Subcutaneous (SC) delivery route has become an emergent alternative to intravenous administration across many disease areas by offering the opportunity to reduce payor costs, increase adherence, and improve the patient’s experience. High injection forces (due to high viscosity of concentrated formulation), prolonged injection time, and increase in perceived pain are major challenges of existing parenteral injection systems limiting SC delivery, especially for large volume, high viscosity biologics including monoclonal antibody and protein formulations.

In this talk I review the formulation and device considerations/challenges when developing a Target Product Profile (TPP) for a SC-delivered product. Then, I highlight early challenges and opportunities in formulation & device development space, considering a broad range of SC drug delivery devices including preloaded microneedle patches, autoinjectors, injection pens, syringes, wearable and implantable systems. Finally, a methodology for technology down-selection and final target image selection will be provided.

Sahab Babaee, Associate Principal Scientist, Merck Research Labs – Program Lead & Device Innovation, Merck