mRNA
From plasmids and in vitro transcription (IVT) to lipid nanoparticle (LNP) formulation and fill/finish, Catalent is your CDMO partner with the expertise and capabilities to help 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 60 mRNA IVT batches manufactured and released to date.
Our plasmid facility in Gosselies, Belgium offers scalable custom mRNA production services. Catalent can also provide high-quality enzymes and linearized plasmid DNA to meet your mRNA project requirements.
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.
We have capabilities across different types of RNAs including:
- Linear mRNA
- Self-amplifying RNA
- Circular RNA (endless RNA)
- Self-replicating
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.
NanoOrange is a registered trademark of Molecular Probes, Inc.