Manufacturing and Process Scale-Up
Continuous manufacturing (CM) of lipid-based therapeutics makes use of process analytical technology (PAT) to ensure critical quality attributes (CQAs). Process refractometers enable inline concentration monitoring, particularly for cryoprotectants. While refractive index (nD) is well-characterized for single-component systems, multi-component systems remain understudied. This work investigates interactions between formulation components and process parameters to enhance refractometry as a PAT tool, improving the efficiency and reliability of CM for lipid-based therapeutics.
Luke Burroughs
Graduate Student
University of Connecticut
Storrs, Connecticut, United States