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This article was just published by Cell and Gene Therapy Insights, “Process & analytical insights for GMP manufacturing of mRNA lipid nanoparticles”.
The absence of standardized protocols means manufactures must develop and optimize their process, leading to a considerable number of process variations. There are many variables and decisions throughout the production workflow that will greatly impact the equipment selection, setup, batch cost, and throughput.
In this article we discuss some of the more challenging steps, highlighting how optimization is key to the whole process.
Readers will learn about:
- The five key steps in manufacture of the mRNA-LNP drug product.
- Important process and analytical considerations and potential bottlenecks.
- Next steps in mRNA-LNP development.
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