A global specialist in Nucleic Acid CDMO services
From standard raw material building blocks to complex oligonucleotides and mRNA, Hongene consistently delivers exceptional quality and value to our customers. Through collaborations, Hongene can help unlock the full potential of nucleic acids to develop life-changing treatments for patients worldwide.
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)