Senior Scientist Regeneron Pharmaceuticals Tarrytown, New York
Biopharmaceuticals are commonly formulated as systemic injections that are administered frequently to maintain efficacy. Drug delivery systems have the potential to improve pharmacokinetics and reduce dosing frequency, however conventional technologies such as microspheres (MS) have limitations in achieving high drug loading and stability of biologics. To overcome these limitations, we developed a non-aqueous emulsification platform to encapsulate dry powder/solid biologics. ’FluoriPack‘ (Fluorinated Packing) is a solid/hydrocarbon/fluorocarbon platform that enables high loading of proteins within MS, minimal drug degradation, and reduced burst release. Preliminary studies with a model spray dried protein (SDP) have revealed promising results with MS surface void of pores/water channels resulting in negligible burst release ( < 10% over 24H). These 30µm size ‘FluoriPack’ MS composed of polyester polymers are currently being evaluated for their long-term stability, release kinetics, and toxicity profile.
Learning Objectives:
Fabricate polymeric microspheres using non-aqueous emulsification technique to encapsulate dry powder biologics.
Conduct in vitro performance testing for microsphere platforms
Understand the advantages of non-aqueous emulsification over conventional techniques for loading dry powder biologics in microspheres
