Continuous flow-based In Vitro Transcription (IVT) improves RNA quality
Platform approach accelerates clinical progression
Scalable from milligrams to grams without process redesign
Integrated services supporting rapid programme progression
Arcinova’s RNA offering provides a comprehensive, end-to-end pathway, including:
- Technology transfer and process development
- GLP toxicology batch manufacture
- GMP CMC engineering batch production (bulk drug product and fill/finish)
- Analytical development, characterisation, and stability studies
- Support for CTD-enabling documentation and regulatory readiness
Programmes can be delivered as fully integrated packages or tailored to individual project requirements, allowing flexible engagement across different stages of development.
Experience Across RNA Modalities
Messenger RNA (mRNA) therapeutics
mRNA therapeutics provide a flexible platform for developing targeted treatments across a range of diseases. Importantly, mRNA is not the medicine itself—it acts as a blueprint, directing the body’s own cells to produce the desired therapeutic protein. By encoding specific proteins, they enable applications from infectious disease vaccines to therapies for genetic disorders and cancer.
Self-amplifying RNA (saRNA) vaccines
saRNA vaccines are an advanced evolution of mRNA technology, designed to achieve strong immune responses with significantly lower doses, unlocking major efficiencies in both cost and manufacturing scale. By amplifying within the cell, saRNA reduces dose requirements and supports faster, more scalable vaccine production.
Lipid Nanoparticle (LNP) and alternative formulation strategies
LNPs protect fragile RNA and ensure efficient delivery into target cells, improving stability, potency, and overall performance. Alongside LNPs, alternative formulation strategies are emerging to enhance delivery, targeting, and stability for next-generation RNA therapeutics.
For inhaled applications, advanced approaches such as polymer-based formulations can be used to deliver therapies directly to the lungs—enabling targeted delivery with improved tolerability compared to LNPs.
Built for Clinical Progression
GMP-ready infrastructure
Integrated development and manufacturing capability
Proven progression from development to tox batches
Our RNA Manufacturing Process
In vitro transcription (IVT)
Continuous, flow-based RNA production designed to maximise yield while minimising impurities. This controlled environment supports consistent synthesis and scalability for a wide range of RNA applications.
Purification
Removal of process-related impurities, including residual DNA, enzymes and unincorporated nucleotides. This step ensures high purity and prepares the material for downstream processing.
Concentration and filtration to deliver drug substance
Precise control of product concentration and buffer exchange using drug substance Tangential Flow Filtration (TFF). This enables consistency, scalability and reproducibility across batches.
Formulation
Encapsulation of RNA into lipid nanoparticles (LNPs) to protect the molecule and enable effective delivery. Formulation conditions are optimised for particle size and encapsulation efficiency.
Drug product preparation
Final concentration adjustment and preparation for fill-finish using drug product TFF, ensuring the product meets required specifications for quality, stability and administration. This step also supports buffer optimisation and removal of residual impurities, helping to ensure a consistent, high quality final product.