Messenger ribonucleic acid (mRNA) encapsulated in lipid nanoparticles (LNPs) is a vaccine modality that has found recent effectiveness and prominence within the biotech and pharma industries. Both the mRNA and LNP are susceptible to physical degradation and may present as fragmentation, aggregation, precipitation, fusion or leakage of mRNA from the LNP during manufacturing operations.
One proposed mechanism of physical degradation is processing of vaccine process intermediate solutions using recirculated pumping during unit operations such as tangential flow filtration (TFF). Some instances of prolonged recirculated pumping involve TFF which is a filtration unit operation used throughout the industry to concentrate and/or diafilter a product pool with a desired buffer. This study evaluates and compares a SU maglev centrifugal pump and a SU quaternary diaphragm pump and their associated physical effects on degradation of the mRNA and LNP fluid streams during typical manufacturing unit operations.
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