The rapid growth of mRNA-lipid nanoparticle (mRNA-LNP) therapeutics has created a need for a better understanding of how LNP properties affect sterile filtration performance. Limited knowledge of the relationships between LNP characteristics, filter fouling, product yield, and filter capacity creates challenges in process development, scale-up, and filter selection for manufacturing.
The project intends to develop a fundamental understanding of how mRNA-LNP properties and sterile filter characteristics influence filtration performance through particle characterization, sterile filtration studies, filter fouling analyses, and predictive modeling. The resulting knowledge is intended to support the selection and design of sterile filtration processes for mRNA-LNP drug products.
The project intends to generate data and predictive insights that improve understanding of sterile filtration performance for mRNA-LNP drug products. This information is intended to support more informed filter selection, process development, manufacturing scale-up, and other decision-making activities for emerging mRNA-based therapies.
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The Pennsylvania State University
