Formulation and Device Considerations for Subcutaneous Delivery

27 September 2022 09:45 - 10:15

  • 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 of biotherapeutics is often preferred over other routes of administration, i.e. intravenous (IV). This presentation provides an overview of subcutaneous products with a focus on those that have developed IV and SC formulations. We will discuss aspects of target product profile (TPP) development critical to enabling SC delivery, both from formulation and delivery device perspectives. Once the TPP is established, the focus then moves towards identifying early challenges and opportunities. This includes deploying a strategy for formulation and delivery technology selection that identifies both innovative (best in class) and robust, risk averse options. We will include in this presentation methods and approaches to leveraging the interplay between formulation and device to down select toward the most appropriate target image.

Steven Persak, Director, Device Development, Merck

William Forrest, Principal Scientist, Sterile & Specialty Products, Merck

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