(317) Novel Non-Aqueous Emulsification-based Microsphere Platform for Sustained Delivery of Proteins

Introduction: Microspheres (MS) have been developed successfully for sustained delivery of small molecules & peptides using an aqueous emulsification platform. However, due to the affinity of biologics to the aqueous vehicle, the development of MS for sustained delivery of mAbs & proteins has been challenging. To overcome low encapsulation & poor compatibility, we have developed a novel non-aqueous emulsification platform (FluoriPack) to encapsulate spray dried protein (SDP). We present the development, optimization, and characterization of solid-protein encapsulated MS formulations using our novel process.