Formulation And Process Development For High-Concentration Subcutaneous Biologics Drug Product

The escalating demand for subcutaneous administration of biologics has necessitated a concomitant increase in drug product concentration. However, the development of such high-concentration formulations presents numerous challenges. These include elevated viscosity, protein aggregation, precipitation, particle formation, and other related phenomena. To address these complexities, researchers have explored various strategies and approaches. Delve into the specific challenges encountered in the development of high-concentration formulations and gain an overview of the current state-of-the-art solutions.