RNA Foundry
We manufacture personalized mRNA cancer vaccines.
The RNA Foundry provides contract research, development, and manufacturing services for personalized cancer vaccines. This is a project of PopVax, a clinical-stage RNA vaccine company, in close collaboration with our colleagues at Stochastic Sciences, which develops personalized medicines.
PopVax is a biotechnology company developing RNA vaccines and immunotherapies, funded by the Gates Foundation, Good Ventures, Vitalik Buterin, and the US Biomedical Advanced Research and Development Authority (BARDA). The RNA Foundry is our integrated R&D and Good Manufacturing Practice (GMP)-compliant manufacturing facility for RNA medicines in Hyderabad, India.
mRNA-LNP Platform
We use the same mRNA and LNP platforms, as well as the same manufacturing processes and quality control protocols, that we used for our broadly-protective COVID-19 vaccine candidate PVX-001, which was developed and manufactured at the RNA Foundry, and has successfully entered clinical trials in Australia.
Our proprietary LNP formulation, based on our ionizable lipid PVXL-150, is stable for 9+ months in a regular refrigerator at 2-8 °C, making it straightforward to transport and store vaccines built on our platform.
In preclinical work for PVX-001, mRNA in this LNP formulation was able to elicit robust CD8⁺ T-cell responses in mice.
The RNA Foundry is operated by our full-stack team of experts across computational vaccine design, molecular and cell biology, immunology, LNP formulation, analytical method development, GMP manufacturing, quality, and regulatory affairs. It can run 24/7 to produce personalized RNA vaccines.
We started this service because we’ve received numerous requests to produce personalized cancer vaccines. Merck and Moderna’s encouraging results with a combination of personalized mRNA vaccines and immune checkpoint inhibitors against melanoma, along with BioNTech and Genentech’s data against pancreatic cancer, suggest that RNA vaccines may become an important part of cancer care regimens across tumour types in the coming years, but regulatory approvals for many cancer types may come too late for many patients living with these diseases today.
In the meantime, these patients and their physicians are pursuing other pathways to receive access to this class of medicine, including compassionate use and expanded-access INDs. Many have been inspired by pioneers like Sid Sijbrandij, the GitLab co-founder who has blazed a trail in personalized medicine, commissioning the development and manufacturing of many new therapeutics for his own cancer, including RNA vaccines. We’re democratizing this capability at the RNA Foundry, with the capacity to make 100+ personalized cancer vaccines over the next 12 months.
Working With Us
If you have already designed an mRNA sequence, or are working with a third party to design one, you can send it to us – we will rapidly assess whether it is compatible with our production process and price out manufacturing to an appropriate quality specification. If you haven’t yet designed an mRNA sequence, we are also able to design candidate vaccine sequences based on tumour sequencing data using our in-house pipeline built around frontier AI models combined with open-source MHC presentation and immunogenicity prediction tools.
Once we are agreed on a sequence, we produce the candidate mRNA sequence in ISO 7/8 cleanrooms, encapsulating it in our LNP formulation and filling it into an agreed number of vials, then run a comprehensive battery of quality control tests on the material before shipping it to you.
You will receive the manufacturing records, analytical results, and a certificate of analysis (CoA) to support your R&D work and regulatory filings.
Quality Control
Below are the key quality control tests we run on the mRNA-LNP vials before shipping them to you:
| Property | Measurement method |
|---|---|
| RNA identity | Sequencing |
| Appearance | Visual inspection |
| Particle size | Dynamic light scattering (DLS) |
| Particle size distribution (PDI) | Dynamic light scattering (DLS) |
| Zeta potential | Electrophoretic light scattering (ELS) |
| pH | Potentiometry |
| mRNA content | RiboGreen fluorescence assay |
| Encapsulation efficiency | RiboGreen fluorescence assay |
| mRNA integrity | Reverse-phase high-performance liquid chromatography (RP-HPLC) |
| mRNA aggregates | Size-exclusion HPLC |
| Osmolality | Freezing-point depression osmometry |
| Endotoxin | Kinetic turbidimetric LAL assay |
| Sterility | Membrane filtration sterility test (USP <71>) |
Request a Quote
If you’re looking for a contract research, development, and manufacturing partner for an mRNA cancer vaccine, we’d love to hear from you. We expect most projects to cost around $300,000 (USD) and take 8-10 weeks. Please email the following information to cancer@rnafoundry.com:
- Your name and the country you want the manufactured material to be shipped to
- The cancer type and stage
- A short description of any available tumour and healthy tissue sequencing data
We will get back to you quickly.