Background
The increasing importance of in vitro transcribed (IVT) mRNA for synthesizing the encoded therapeutic proteins in vivo (as therapeutic proteins or vaccines) demands the manufacturing of pure messenger RNA (mRNA) products. mRNA is synthesized through a four-step process: linear plasmid production, in vitro transcription (IVT), purification and final quality control. It is imperative that the manufacturing process is closely regulated, and manufacturers must meticulously monitor critical quality attributes. This ensures consistency across lot-to-lot production and proof of purity. It also guarantees control over process and product related impurities maintaining them at levels within the acceptable limits as per regulatory guidelines.[2]
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