RUO Materials Preparation
Process Development
Enorna's state-of-the-art GMP manufacturing campus is located in the Yixing Life Science Park. The facility spans over 6,000 square meters, featuring 2,000 square meters of office space and 4,000 square meters dedicated to GMP production.
It is specifically designed to support the end-to-end development and manufacturing of nucleic acid therapeutics, integrating capabilities from plasmid DNA preparation and mRNA synthesis to LNP formulation, aseptic filling and lyophilization.
Full Coverage of Nucleic Acid Drug Development Life Cycle
Plasmid DNA Production
RNA Production
Fill/finish & Lyophilization
LNP Formulation
Total Footprint
6,000 m2Office Space
2,000 m2GMP Facility
4,000 m2
Repligen TFF (Tangential Flow Filtration) systems
Cytiva AKTA Pilot 600 chromatography systems
High-throughput microfluidic LNP preparation systems
Fully automated fill-finish/lyophilization lines
Malvern Ultra particle size analyzers
Thermo Fisher LC-MS
Thermo Fisher Vanquish UPLC+CAD/UV detection systems
Beckman capillary electrophoresis instruments
Real-Time PCR (qPCR) systems
NanoFCM
All equipment has undergone rigorous IQ/OQ/PQ validation, supporting a robust quality assurance system that provides reliable data for regulatory filings and ensures the delivery of safe, effective, and quality-controlled products.
RUO Materials Preparation
Process Development
GMP plasmid production
GMP RNA Production
mRNA, circRNA, saRNA, etc.
LNP GMP production
Aseptic filling
Lyophilization
RNA-based PCV GMP
Productions
Assay development
and qualification
Analytical testing
*Lyo: Lyophilization
**PCV: Personalized Cancer Vaccine
Tel. +86 18961517608
E-mail. bd@enorna.com
Address.
63 Keji Avenue,
Bldg. 6, Fl. 6,
Yixing, Jiangsu, China
