High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

Cindy Chung, Ph.D

Prinicipal Engineer

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Abstract:

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. Vehicle selection is key to developing a stable product with an acceptable target product profile.    

In this work, we focus on evaluating suspension vehicles to understand how vehicle composition impacts the relationship between suspension concentration and syringe dispensing force. We also explore vehicle impacts on suspension and protein stability as a function of time at an accelerated storage condition.

‍In this case study where protein particles are spray dried and suspended in three vehicles at varying suspension concentrations (25%-70% solids). Dispensing forces are measured in 1mL syringes with 27-gauge needles that are compatible with standard autoinjectors.  

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Learning Objectives:

Understand the importance of speciation in amorphous solid dispersions

Understand the differences between polymer colloids formed from different polymers used in amorphous dispersions

Understand how molecular properties can influence the interactions between drugs and polymers