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Plasmid DNA is a stable, circular double-stranded DNA molecule used to carry foreign genes and has become indispensable in gene therapy (CGT), vaccine development, and gene editing. It serves as a foundational component across multiple therapeutic modalities, offering advantages in safety, manufacturability, and regulatory clarity. Depending on the application, plasmid DNA may function as the final drug substance or as a crucial starting material for nucleic acid-based medicines, viral vector systems, or RNA-based therapeutics. Key applications include:
With the global rise in CGT-related clinical trials and regulatory filings, GMP-compliant, analytically qualified plasmid DNA has become a rate-limiting factor in the development of therapeutic products. Developers require not only fast turnaround but also full alignment with CMC, stability, and regulatory expectations.
Creative Biogene delivers high-quality plasmid DNA manufacturing services from research to GMP-grade levels, backed by purpose-built facilities and proven compliance systems. Our GMP-qualified production infrastructure supports global regulatory standards and offers modular services adaptable to specific development phases and regulatory demands.
PRECLINICAL
IND
CLINICAL TRIALS
BLA
COMMERCIAL
Research-grade
GMP-like
GMP-grade
Industrial-Grade Plasmids, GMP-Aligned and Scalable.
Broad Strain and Vector Compatibility
Supports a wide range of E. coli strains and plasmid backbones (high-copy/low-copy, various antibiotic resistances), enabling flexible adaptation for diverse research and production needs.
High-Density Fermentation System
Achieves yields of >1.5 g/L with scalable fermentation volumes from 1L to over 100L, supporting seamless transition from research to pilot-scale production.
Chromatography-Based Purification Platform
Utilizes multi-step column chromatography (e.g., anion exchange, affinity, hydrophobic interaction) to ensure high purity and recovery, meeting pharmacopoeia and regulatory standards.
Automated Grade A Isolator Fill-Finish System
Employs fully enclosed Grade A isolator technology for aseptic, automated filling, eliminating cross-contamination risks and ensuring drug-grade plasmid packaging safety.
Modular Workflow Customization
Each stage of production is customizable to meet specific requirements for mRNA precursors, AAV vectors, CRISPR plasmids, or naked DNA therapeutics, ensuring optimal performance and quality.
Creative Biogene operates under GMP principles and adheres to international regulatory frameworks. Our quality management system ensures traceability, consistency, and documentation integrity from seed bank development through plasmid release.
Table 1. QC Testing Items for Plasmid DNA Release
| Test Item | Specification | Notes |
| Supercoiled DNA content | ≥90% (HPLC) | High expression compatibility |
| Endotoxin level | ≤0.005 EU/μg | Suitable for injectable-grade and cell therapies |
| Host genomic DNA | ≤5% (qPCR) | Minimizes immunogenicity and mutagenic risk |
| Host RNA residual | Non-detectable (≤500 ng) | Enhances purity and expression efficiency |
| Host protein residual | ≤1% | Improves stability and safety |
| Insert sequence fidelity | 100% match | Verified by Sanger sequencing |
| Restriction enzyme map | Matches the theoretical map | Validates plasmid integrity |
| A260/280 ratio | 1.8–2.0 | Indicates protein contamination |
| A260/230 ratio | >2.0 | Reflects the removal of organic impurities |
| Appearance | Clear, transparent, no visible particles | Visual QC |
| pH value | TE buffer 8.0 ± 0.5, PBS 7.2 ± 0.5, WFI 6.0 ± 1.0 | Buffer compatibility check |
| Bioburden test | Sterile after 48 hours of incubation | Required for GMP release |
| Mycoplasma testing | Negative | Regulatory compliance |
| Antibiotic residue | ELISA<1.125 ng/ml | Kanamycin or other selection markers |
| Animal-derived component | Animal-free statement available | Eliminates viral contamination risk |
We offer professional regulatory writing and consulting support for local and global submissions, accelerating your time to IND or BLA:
Our team has supported successful registrations across FDA, EMA, NMPA, PMDA, and MFDS, with deep experience in pre-IND, Phase I/II, and commercial filings.
At Creative Biogene, we understand that plasmid DNA is not just a raw material but a critical determinant of product efficacy and regulatory success. From plasmid design through GMP batch release, we deliver comprehensive services marked by speed, compliance, and quality. Whether your goals include high-throughput research-grade production, IND-enabling GMP batches, or commercial-scale plasmid supply, Creative Biogene offers a scalable, professional platform to advance your innovations.
Linearized Plasmid GMP Production
GMP Plasmid Production Process
1. What upstream and downstream strategies do you use to minimize endotoxin and host cell impurity levels?
Our platform combines engineered low-endotoxin bacterial strains, optimized lysis protocols, and multiple chromatographic steps (anion exchange, HIC, size exclusion) to reduce host contaminants. Endotoxin is typically controlled to ≤0.005 EU/μg, with residual DNA, RNA, and proteins consistently below regulatory thresholds.
2. What scale can you support for GMP-grade plasmid manufacturing?
We offer flexible scales ranging from 1L to 100L and beyond. Our process is scalable and validated for upstream fermentation and downstream purification. Commercialization-phase clients benefit from tech transfer packages and long-term supply planning.
3. Do you offer support for process and analytical method transfer to other CDMOs or in-house facilities?
Yes. We provide complete technology transfer packages including SOPs, process descriptions, equipment lists, method protocols, and on-site tech transfer training if required. We facilitate seamless collaboration with downstream manufacturing or viral vector production partners.
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