From plasmids and in vitro transcription (IVT) to fill/finish, Catalent has the expertise and capabilities to help you bring your mRNA therapy or vaccine to clinic and market. We have demonstrated capability to handle and process mRNA with proven experience in tech transfer and over 45 mRNA CGMP batch lots manufactured and released to date.
The flex suite in our Madison, Wisconsin facility is a CGMP manufacturing space comprised of three rooms with procedures in place for gowning and materials handling with 1-50L single-use and 2-35L glass IVT reactors.
Our analytical capabilities include:
- RNA content by UV-Vis
- Purity by IRRP HPLC
- Residual DNA by RT-qPCR
- Residual protein by NanoOrange®
- Potency by cell-free translation
- Methods to analyze RNA-lipid complexes also available
Our global fill/finish network enables filling into liquid vials, lyophilized vials, and pre-filled syringes in the US or EU based on your supply needs. Combined with our clinical supply logistics capabilities, we have experience with cold-chain supply/shipping chain of custody, with multiple drug substance formulations supported to supply your clinical and commercial needs.
Additionally, our plasmid facilities in Gosselies, Belgium and Rockville, Maryland offer scalable custom mRNA production services. Catalent can also provide high-quality enzymes and linearized plasmid DNA to meet your mRNA project requirements.
NanoOrange is a registered trademark of Molecular Probes, Inc.