Plasmid DNA CDMO Services
We offer a range of plasmid DNA manufacturing services to meet the needs of your specifications and applications, ranging from preclinical research studies, to clinical trials, and commercial manufacturing. We can manufacture using your existing plasmid or generate a custom plasmid according to your exact needs. We also offer complete upstream and downstream process development support for any plasmid DNA production project, as well as fill/finish capabilities.
| Plasmid DNA Manufacturing Services | Application | Production |
|---|---|---|
| Research-Grade Plasmid | In vitro R&D or preclinical studies | R&D Grade Production Lab |
| High Quality (HQ) Plasmid | Toxicology, GMP vector production for Phase I-II clinical trials, and as template for GMP mRNA | Dedicated Segregated Non-GMP Lab (5 weeks to supply) |
| CGMP Plasmid | Phase I, II, III and commercial viral vector manufacturing, DNA vaccines | GMP Clean Room Suite (10 weeks to supply) |
Plasmid DNA Manufacturing Comparison
| Plasmid DNA Production Conditions and Options | Research-Grade Plasmid | High Quality (HQ) Plasmid | CGMP Plasmid |
|---|---|---|---|
| Cloning/Synthesis/Mutagenesis of plasmid (optional) | ✓ | ✓ | ✓ |
| Scale-up and manufacturing of existing plasmid constructs | ✓ | ✓ | ✓ |
| Multiple production scales (shake flask through fermenters) | ✓ | ✓ | ✓ |
| Proven manufacturing and purification processes for high yield and recovery | ✓ | ✓ | ✓ |
| Standardized manufacturing platforms* | ✓ | ✓ | |
| Establishment of E. coli master and working cell banks | ✓ | ✓ | |
| Upstream process development (optimization of transformation and culture conditions, strain, etc.) | ✓ | ✓ | |
| Downstream process development (optimization of purification and formulation conditions) | ✓ | ✓ | |
| Full traceability of materials | ✓ | ✓ | |
| Full room changeover prior to each production | ✓ | ✓ | |
| Production in segregated and dedicated space | ✓ | ✓ | |
| Process and change control | ✓ | ✓ | |
| Aseptic fill/finish and vialing** | ✓ | ✓ | |
| Document support for IND and IMPD filing | ✓ | ✓ | |
| Master Batch Records (client-specific) | ✓ | ✓ | |
| Stability studies (optional) | ✓ | ✓ | |
| Product release tests | ✓ | ✓ | |
| Manufacturing in CGMP suite with graded air | ✓ | ||
| Complete QC monitoring throughout production process | ✓ | ||
| QA Oversight for production | ✓ |
*RNase A and RNase A free processes available.
**High Quality plasmid is vialed in an ISO 5 BSC non-controlled room. CGMP plasmid is vialed in an ISO 5 environment.