Principal Engineer SerĂ¡n Bioscience, LLC Bend, Oregon
With a growing interest across the industry for subcutaneous delivery of high concentration protein therapeutics, suspension formulations comprised of solid-state protein particles suspended in non-aqueous vehicles offer a platform approach. This approach overcomes the limitation of high protein solution viscosities that require larger needles for delivery and can improve product shelf life. In this talk, we will discuss the impact of vehicle selection on syringe dispense force and product stability. We will present a case study where spray dried protein particles are suspended in three neat vehicles at varying concentrations and discuss the impacts of solids loading on viscosity and glide force. We will also discuss how vehicle impacts particle and protein stability when stored at accelerated storage conditions as a suspension.
Learning Objectives:
discuss important considerations of vehicle selection for the development of an injectable protein suspension drug product for subcutaneous delivery.
understand the relationship between viscosity and glide force for high concentration protein suspensions.
understand the impacts of vehicle selection on protein suspension drug product stability.