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"Quality and consistency of TheraPure GMP N1-methylpseudouridine triphosphate"

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When choosing raw materials for mRNA production, many process development scientists often focus on a few familiar product quality attributes such as analytical quality, use of animal origin–free (AOF) materials, and even cost. However, there are many other product quality attributes that are just as important to consider. Many of these attributes can have a significant effect on not just regulatory approval of a drug but also the development timeline and commercial manufacture of a drug.

Presented here is an analysis of some of the key product quality attributes of a modified nucleotide product, and their impact on the development and manufacturing of a therapeutic. This study not only demonstrates the analytical quality of the product but also addresses many of the other key product quality attributes of a material that help make it suitable for current good manufacturing practice (cGMP) production of an mRNA therapeutic or vaccine.

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