The idea of using messenger RNA (mRNA) as a drug or vaccine has interested scientists for decades. It transiently passes genetic information to the protein factories inside our cells, and can be engineered to tell this machinery what to make to fight, or prevent, disease.
For therapeutic use, mRNA has advantages. It acts without entering the cell nucleus, degrades without leaving behind unwanted or harmful genetic traces, and it can instruct cells to make almost any protein.
Early challenges limiting clinical use were overcome by technology advancements focused on mRNA nucleoside modifications and structural elements such as the cap, tail and untranslated regions, and this has led to ground-breaking experimental therapies that are now showing promise in clinical stages of development.
Dealing with risk, time and results
Making synthetic mRNA for rapidly growing research and clinical uses presents new challenges in terms of manufacturing capacity and capability. Aldevron is meeting these challenges by expanding our services to satisfy a wider and more demanding range of needs. We now offer standardized kit-scale production plus semi-custom manufacturing of mRNA by in vitro transcription (IVT) for research use, and we are launching GMP-SourceTM and GMP-grade services later this year for clinical applications.
To reduce supply chain risk, minimize lead time and ensure consistent results, Aldevron manufactures and QC tests the DNA template and recombinant enzymes for in vitro mRNA synthesis. And we can supply these critical components to your mRNA production in research through clinical stages of development.
The steps of synthetic mRNA production at Aldevron typically involve gene synthesis followed by plasmid DNA template generation and preparation. The template is linearized, purified and transcribed in vitro, and the cap and tail structures are added enzymatically.The resulting mRNA is purified by column chromatography and formulated.
Our mRNA production options include modified nucleosides, template-encoded poly(A) tail, and co-transcriptional capping with cap analogs. Clincal grade production additionally offers a comprehensive and customizable panel of QC tests.
Aldevron is committed to meeting your specific requirements for synthetic mRNA, from screening many constructs to scaling up for preclinical and clinical stages. If you would like to discuss available development options, contact us about what we can offer you.