1. Process development
We develop a manufacturing method using non-GMP plasmid vectors with small-scale studies. We also develop and validate test methods for in-process controls and standards.

2. Test manufacturing
We perform test manufacturing at performed at scale using GMP-grade plasmid DNA.

3. Final mRNA production
We use GMP-grade plasmid DNA to manufacture mRNA. We can manufacture from tens to hundreds of liters of product depending on your application.

GMP-grade mRNA production general workflow

During process development, we develop and validate several in-process controls and standards based on your mRNA manufacturing requirements. Details of quality testing and characteristic analysis are decided on after consultation and may include the following:

• mRNA concentration test
• mRNA purity test
• Sterility test
• Endotoxin test
• Microbial limit test
• Poly(A) chain length confirmation test
• Base sequence confirmation
• Residual testing (dsDNA, DNA, protein)

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