CDMO Services
Vertically integrated CDMO services for oligonucleotide and mRNA therapeutics
From raw materials to GMP drug product: Fewer handoffs, faster timelines, greater confidence
Hongene simplifies complex supply chains
By combining raw material production with advanced oligonucleotide and mRNA CDMO services. This vertically integrated model reduces handoffs, accelerates timelines and ensures regulatory alignment at every stage of development.
Our Services
Pre-clinical
Clinical
Commercial
Building Blocks
In-house manufacture of all key raw materials
API
Process development, analytical development, manufacturing, and quality control
Drug Products
Formulation, fill & finish, lyophilization
Service Scope
CMC
- Process development & optimization
- Formulation development
- non-GMP and GMP batches
- FTE Model
Analytical
- Analytical method development & validation
- Impurity Profile Analysis
- Testing of raw materials, intermediates and crude APl
- Stability testing under the lCH requirements
- Release testing
Commercial Manufacturing
- Process Performance Qualification (PPQ)
- GMP manufacturing trains
- Support global regulatory filing (CDE/FDA/EMA)
Oligonucleotide CDMO
From early development to tonne-scale GMP production, we support complex oligonucleotide programs with speed and precision.
- Process and analytical development
- Chemoenzymatic ligation for scalable, high-purity siRNA, sgRNA and other oligonucleotides
- GMP production with up to tonne scale
- QC, regulatory support, and release testing
mRNA CDMO
Complete in-house control of mRNA raw materials — from enzymes to lipids — through to GMP manufacture and fill–finish.
- Plasmid DNA template generation and linearization
- One-pot in vitro transcription (IVT) (integrated plasmid linearization and transcription)
- Capping with HiXCap™ for improved translation efficiency
- Purification and QC (≥98% full-length, dsRNA <0.01%)
- LNP formulation, lyophilization, aseptic fill–finish
Custom synthesis
- Custom-built raw materials for RNA innovation
- Core building blocks （standard and custom phosphoramidites）
- Modified chemistries (ribose, backbone, nucleobase, conjugates)
- Specialty reagents (HiXCap™, linkers, novel monomers)
- Rapid turnaround for bespoke requests
