The majority of protein therapeutics continue to be delivered through IV administration due to the requisite high doses. Enabling subcutaneous delivery of protein therapies often requires technologies capable of delivering up to gram quantities of protein. High concentration formulations are often limited by protein stability and solution viscosity. As an alternative approach, suspension formulations comprised of solid-state protein particles suspended in non-aqueous vehicles can provide a platform approach to enable ultra-high protein concentrations. Using spray drying, a versatile and high throughput operation, we demonstrate how particle engineering and formulation development can be optimized together for delivery and protein stability. This case study, addressing protein stability and suspension viscosity, presents the development of a high concentration bevacizumab suspension at up to 400-500 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy.
Learning Objectives:
Upon completion, participant will be able to understand molecule specific aspects of product design that need to be considered for each unique protein for ultra-high concentration protein suspensions.
Upon completion, participant will be able to understand the dose delivery capabilities for spray dried protein suspensions using bevacizumab as a case study.
Upon completion, participant will understand how particle and vehicle properties can be optimized to improve protein delivery performance using bevacizumab as a case study.
Upon completion, participant will be able to discuss the stability of bevacizumab as a spray dried protein suspension.
