Plasmid DNA

Cost-Effective Plasmid Production Strategies Tailored for Diverse Application Scenarios

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As critical starting material for nucleic acid drug manufacturing, purity, stability, and quality of plasmid DNA directly impact the safety, efficacy, and process stability of final drug product. Leveraging our mature plasmid production processes and robust quality management system, Enorna develops flexible production strategies tailored to different application scenarios and development stages. We provide clients with full plasmid CDMO services, spanning from preclinical research to commercial-scale production.

Services

Enorna offers phase-appropriate and flexible plasmid production services, providing ideal raw materials templates for nucleic acid drug development workflow. Additionally, we provide comprehensive plasmid CMC development services to fully support IND filing and regulatory application.

 
GMP-READI Grade
GMP Grade
E.coli Cell Banking
RCB
MCB
High Density Fermentation
Yes
Yes
Alkaline Lysis
Yes
Yes
Chromatography Purification
Yes
Yes
Release Test
Critical Quality Attributes
Comprehensive Release Testing
CoA
Yes
Yes
QA Oversight
Focused Supervision
Comprehensive Control
Manufacturing Process
Platform Process
Developed & Validated Process
Production Environment
GMP Facility
GMP Facility
Manufacturing Process and Advantages
01

E.Coli Cell Banking

02

Seeding

03

Fermentation

04

Alkaline Lysis

08

Release Test

07

UF/DF

06

Chromatography

05

UF/DF

Proprietary High-Quality Process

High-Density Fermentation: Optimized for maximizing plasmid yield.

Chromatographic Purification: Effectively remove impurities, including residual host cell DNA, RNA, proteins, endotoxin, etc.

Animal-Derived Component-Free (ADCF): Ensuring product safety and regulatory.

High Poly(A) Retention: Specialized processes to maintain the stability and integrity of Poly(A) tail.

Superior Linearization: Achieving a plasmid linearization efficiency of >95%.

  • Case
    Plasmid Linearization Ratio
    Case
    Plasmid Linearization Ratio

    Plasmid linearization is a critical step in mRNA IVT. A higher linearization ratio leads to a more stable IVT process, superior mRNA product quality, lower immunogenicity, and reduced production costs.

    By optimizing enzyme digestion systems and purification processes, Enorna maintains plasmid linearization ratios >95%, ensuring high-quality mRNA.

Flexible Scaling and Production Strategies

Phase-Appropriate Approach: Implementing flexible strategies to provide customized plasmid production solutions tailored to different application scenarios and development stages.

Scalable Supply: Flexible production scale ranging from milligram (mg) to gram (g) scales to meet diverse project requirements.

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