Technical report: Performance model mRNA products

DoE of multiple inputs of IVT to develop a performance model optimized for yield and quality of the mRNA product

Therapeutic mRNAs and vaccines are being developed for a broad range of human diseases, including COVID-19. However, optimizing mRNA production is complicated by interdependencies among factors of the in vitro transcription (IVT) reaction that impact yield and quality.

Here, we employ the design of experiment (DoE) approach to analyze the influence and interdependence of factors (T7 RNA polymerase concentration, DNA template amount, and use of modified versus unmodified ribonucleotides) to develop an IVT performance model for assessing process performance using yield, integrity, and purity data of the mRNA product.

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