mRNA-based therapeutics represent a promising new modality for therapies and vaccines. However, process understanding of the CQA and CPP interplay is still developing across the industry. As such, the lack of immediate feedback on the process state during process optimization, sometimes delayed by weeks and limited by throughput, represents a major bottleneck in mRNA commercialization.
The PATfix™ mRNA analytical platform enables reliable at-line insight during process development and production of mRNA-based therapeutics. The ability to resolve key IVT reaction components (NTPs, capping reagent, template, and mRNA), allows both USP and DSP process insight, with a single analytical tool.
The PATfix mRNA platform has now 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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