Lyophilization of LNPs in 96-well plate - A high-throughput approach for excipient screening of freeze-dried LNPs
Eleni Samaridou – Head of Early-stage Formulation Development & Process Design team, Merck Life Science KGaA; Johanna Simon – Head of Formulation Discovery & Analytical Characterization, Merck Life Science KGaA
PhD candidate University of Heidelberg; Merck Life Science KGaA Darmstadt, Hessen, Germany
Introduction: Lyophilization is a strategy widely adopted in the pharmaceutical industry to improve the long-term stability of sensitive pharmaceuticals, such as lipid nanoparticles (LNPs). Yet, developing a robust lyophilization method requires capital and time intensive optimization of numerous critical process parameters (CPP) [1]. One CPP that significantly impacts the critical quality attributes (CQA) of the LNP, and the efficiency of the process, is the selection of proper stabilizing excipients to improve LNP stability during lyophilization [2]. This study evaluates lyophilization in 96-well plates as a high-throughput and cost-effective platform for excipient screening in freeze-dried LNPs.
Learning Objectives:
Conduct freeze drying in 96-well plate as a small-scale, high-throughput approach to screen freeze-dried LNPs.
Accelerate formulation development by fast evaluation of optimal excipient combinations based on CQAs of LNPs.
