Enorna provides end-to-end CMC solutions and has successfully supported gene editing drug programs in achieving IND clearance from both FDA and NMPA, demonstrating deep expertise in CMC development for gene editing programs. Tailored to the unique characteristics of gene editing therapeutics, we enable mRNA-LNP gene editing drugs with high concentration, low residuals, and precisely controlled RNA component ratios, ensuring clinical safety and efficacy.
Enorna is your partner in advancing gene editing therapies from concept to clinic, accelerating the vision of "one-time cure" therapeutics.
mRNA-LNP-based gene editing therapeutics require injection doses thousands of times higher than preventive mRNA vaccines to ensure editing efficacy, presenting significant CMC challenges. Additionally, multi-component co-encapsulation imposes stricter demands on downstream processes.
Supercoiled Plasmid Production
Plasmid Linearization
mRNA Drug Substance Production
mRNA + gRNA Co-Encapsulation
Release Testing
Aseptic Fill-Finish
Sterile Filtration
Purification
Supports drug substance production for various gene editors, including mRNA, circRNA, and saRNA
From linearized plasmid template to mRNA IVT, the process ensures low dsRNA formation to minimize immunogenicity
Multiple purification steps remove process-related impurities to ensure safety at high-dose administration
Achieves efficient co-encapsulation of gene editor-encoding mRNA and gRNA
Multi-component ratios are precisely controllable with excellent batch-to-batch consistency
Encapsulation concentrations of up to 3.8 mg/mL have been achieved while maintaining >95% encapsulation efficiency
Experience in developing and scaling up 25+ novel lipid formulations
Experience in GalNAc-LNP active liver targeting process development
Experience in antibody-conjugated LNP extrahepatic targeting process development
Through synergistic optimization of LNP formulation and process, mRNA encapsulation concentrations of up to 3.8 mg/mL have been achieved, with encapsulation efficiency consistently maintained at >95%.
This significantly increases mRNA payload per unit volume, enabling gene editing therapies to achieve high-dose delivery with smaller injection volumes—enhancing safety while offering greater flexibility for precise tissue targeting.
Leveraging its leading LNP delivery technology platform, Enorna has completed process development and scale-up for 25+ novel lipids. Key quality attributes are outstanding, with an average encapsulation efficiency of 96% and an average polydispersity index (PDI) as low as 0.1.
As a CDMO focused on LNP delivery technology, we leverage our deep expertise in novel lipid process development to provide one-stop support—from development to scale-up—for your novel lipid formulations, accelerating mRNA gene editing therapies to patients.
Enorna provides comprehensive CMC and GMP manufacturing services for mRNA-LNP gene editing therapies, supporting lab-scale process development starting from gene sequences, preclinical sample production, global regulatory submissions, GMP manufacturing at various clinical stages, and commercial-scale production.
Lab-Scale Process Development
Rapid IIT Sample Production
Comprehensive CMC Development Services
Plasmid-mRNA-LNP Process Development
Analytical Method Development and Validation
IND Submission and Regulatory Support
GMP-Grade Plasmid and mRNA Drug Substance Manufacturing
GMP-Grade LNP Manufacturing
GMP-Grade Aseptic Fill-Finish
Commercial-Scale Batch Production
Reach Out Today
Contact us
Tel. +86 18961517608
E-mail. bd@enorna.com
Address.
63 Keji Avenue,
Bldg. 6, Fl. 6,
Yixing, Jiangsu, China
