Optimize Your mRNA Process from pDNA Template to LNP Encapsulation with a Single Analytical Platform

Blaž Bakalar, Product Manager PATfix platform, Sartorius BIA Separations

mRNA-based therapeutics represent a promising new modality for therapies and vaccines. However, industry-wide process understanding of the CQA and CPP interplay is still developing. As such, the lack of immediate feedback on the process state during process optimization, sometimes delayed by weeks and limited by throughput, represents a big bottleneck in mRNA commercialization. The PATfix mRNA analytical platform enables reliable at-line insight during process development and production of mRNA-based therapeutics. With an ability to resolve key IVT reaction components (NTPs, capping reagent, template and mRNA), both USP and DSP process insight can be gained, with a single analytical tool. The PATfix mRNA platform has been upgraded to include LNP encapsulation analytics, enabling at-line monitoring of a crucial process step on the path from mRNA drug substance to LNP drug product.

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