mRNA CDMO
mRNA CDMO Services
A vertically integrated platform for mRNA vaccines and therapeutics, accelerating the development and delivery of life-saving treatments.
End-to-end mRNA CDMO Services
How does Hongene’s mRNA CDMO workflow support end-to-end development?
Hongene’s mRNA CDMO workflow supports end-to-end development by integrating raw materials, IVT, GMP manufacturing, analytical development, and drug product services within a single platform.
- ISO- and GMP-grade NTPs, cap analogs, lipids and enzymes
- Plasmid DNA (pDNA) expression and linearization for IVT templates
- mRNA sequence and chemistry design to enhance protein production, stability and immune modulation
- Process and analytical development, including method qualification, validation, and scale transfer
- Large-scale GMP manufacturing of clinical- and commercial-grade mRNA
- Comprehensive quality control, ensuring purity, potency, and safety
- LNP formulation and Fill & Finish into final injectable dosage forms (vials or syringes)
State-of-the-art Facility
What manufacturing capacity and infrastructure supports mRNA development at Hongene?
Our mRNA facility is equipped with advanced technology and processes to ensure efficient, high-quality production of mRNA therapeutics and vaccines. It consists of more than 30,000 square feet of laboratory and GMP manufacturing. It supports the production of non-GMP products for formulation development and toxicology studies, as well as GMP products for early and late-stage clinical trials. Operations commenced in 2021.
Comprehensive In-House mRNA Raw Material Supply
What is the impact of raw material quality on mRNA drug substance quality?
High-quality raw materials directly impact mRNA drug substance quality by ensuring consistency, purity, and regulatory compliance across manufacturing. We produce a complete portfolio of mRNA raw materials in-house, including:
- Nucleosides and nucleotides (standard and modified)
- Enzymes and cap analogs
- Ionizable lipids and excipients for LNP formulation
How does vertical integration reduce risk in mRNA manufacturing programs?
This vertically integrated approach ensures consistent quality, secure supply, and full traceability, freeing our partners to focus on mRNA design and development, without raw material sourcing concerns.
Deep RNA Expertise
How does Hongene support different mRNA modalities such as saRNA and circRNA?
Hongene supports a range of mRNA modalities, including saRNA and circRNA, through tailored sequence design, chemistry optimisation, and collaborative development approaches.
- Conventional mRNA
- Self-amplifying mRNA (saRNA)
- Circular RNA (circRNA)
We collaborate closely with clients to tailor sequence and chemistry, optimize yields, and accelerate development timelines, bringing RNA programs from concept to clinic with scientific precision and manufacturing excellence.
Ready to advance your mRNA program?
