High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

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

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Cindy Chung, PhD

Principal Engineer, Process and Product Development

With a fascination of the human body and a desire to make an impact on peoples' quality of life, Cindy has focused her interests in healthcare and medicine. After her post doctorate fellowship on understanding cells and 3D microenvironments at Stanford, she made the jump to industry to be involved in products with real world impacts on peoples' health. For the past 2.5 years she has been in the CDMO space, specializing in formulation development of drug product intermediates and drug products for both small molecules and biologics. Prior to this, Cindy has 6 years of industry experience in healthcare in vitro diagnostics and 1 year of experience in ocular therapeutics.

She has PhD in Bioengineering from the University of Pennsylvania and a BS in Chemical Engineering with a minor in Bioengineering from MIT.

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