Develop
mRNA process development
We engineer a robust, transferable manufacturing process around your construct. Design-of-experiments studies, scale-down models, and material-attribute mapping deliver a process that performs the same on the floor as it did at the bench.
Manufacture
mRNA drug substance manufacturing
GMP production of mRNA drug substance via IVT — template linearization, transcription, capping, tailing, and purification — in single-use, closed-system suites from clinical batches to commercial scale.
Formulate
LNP encapsulation & formulation
FluxMix™ microfluidic encapsulation, buffer exchange, and formulation that turn purified RNA into uniform, well-characterized lipid nanoparticles ready for dosing.
Fill
Drug product manufacturing
Aseptic fill-finish of formulated LNP drug product, including sterile filtration, vialing, visual inspection, and cold-chain-ready packaging under cGMP.
Characterize
Analytical development
Phase-appropriate method development, qualification, and release testing purpose-built for RNA and LNP — identity, integrity, capping, encapsulation, potency, and residuals.
Transfer
Technology transfer
Inbound or outbound, we mirror your process and methods with a dedicated transfer team, structured documentation, and milestone-gated de-risking at every scale.