Serán to Present at AAPS National Biotechnology Conference

High Concentration Protein Suspensions: A Case Study for Subcutaneous Delivery of Bevacizumab

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Erica Schlesinger, PhD

Wednesday, May 15th 2:30 PM – 3:30 PM

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Purpose:

There is a growing interest across the industry in developing technologies for subcutaneous delivery of high dose protein therapeutics. High concentration protein solutions are limited in their application to this space by viscosity and stability; both phenomena are driven by protein-protein interactions in solution. High concentration suspensions have the potential to address both the syringability and stability challenges as well as to provide a broadly applicable technology platform. Spray drying is one technique available for the production of protein microparticles suitable for incorporation into suspension. This case study presents the development of a high concentration protein suspension (400-500 mg/mL) suitable for subcutaneous delivery of monoclonal antibody (mAb) and considers both protein stability and suspension viscosity.

• High concentration protein suspensions enable subcutaneous delivery of protein therapeutics at efficacious doses
• Spray drying is an established unit operation capable of producing particles engineered for optimal suspension performance
• Particle porosity is a key attribute impacting suspension viscosity‍

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