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High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

High Concentration Protein Suspensions: Optimizing the Suspension Vehicle

Cindy Chung, Ph.D

Prinicipal Engineer

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 arecompatible with standard autoinjectors.  

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

About Serán

Serán BioScience, LLC, is a science-driven Drug Development Partner, recognized as a world leader in drug development. Utilizing a foundation of physical and chemical science, Serán designs robust formulations and engineered solutions to some of the industry's toughest drug product problems. Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product. Serán’s team has decades of experience developing complex drug molecules into enabling medicines. With every addition to our team, we further our commitment to our clients’ success. From preclinical to GMP and beyond, Serán is here to support you and your drug product every step of the way.

For more information, visit www.Seranbio.com or email us at hello@seranbio.com.

Contact

Serán BioScience, LLC
63047 Layton Ave, Bend, OR 97701 USA
www.seranbio.com

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Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product.

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