INDReady®
GMP-like production for preclinical and clinical applications
As your work moves to early-phase clinical trials, our quality system ensures your plasmid DNA is manufactured in compliance with fundamental GMP principles and Puresyn SOPs. You can be confident that the final product specifications have been met and the DNA product is of the highest quality and suitable for use in GMP production.
INDReady® plasmid DNA is backed by our exceptional quality systems
Puresyn’s production process utilizes our proprietary PolyFlo® resin (DMF 13090) and moves through a dedicated state-of-the-art ISO Certified cleanroom facility.
Our quality systems include:
- Equipment maintenance and calibration programs to ensure high-quality outputs
- Robust training to ensure employees are qualified and trained appropriately
- Segregated processes and dedicated components to reduce the risk of cross-contamination
- Robust documentation procedures that require review of all completed processing documentation, changes, and deviations, and regular audits of current systems
- Quality oversight of sample handling and tracking is performed throughout the INDReady® process
- Documentation packages available for regulatory submissions
Custom premium INDReady® plasmid DNA specifications
| PARAMETER | SPECIFICATION |
| Appearance | Clear, colorless, no visible particulates |
| Sterile fill | Sterile filled by quality |
| A260:280 | 1.7-2.0 |
| Concentration | Amount ordered (mg) / 10ml |
| DNA homogeneity | ≥90% |
| Residual RNA | None detected @ 1.0µg load |
| ssDNA, chromosomal DNA | None detected @ 1.0µg load |
| Linear DNA | <3% |
| Protein | Reported |
| pH of final product | 7.5-8.5 |
| Endotoxin | <30 EU/mg |
| Identity | Information for 4 restriction reactions |
| Five-day bioburden | No growth on plates |
| Bottling | Collaborator defined |
| Sequencing | Coming soon |
| Mycoplasma testing | Coming soon |
| Sterility testing | Coming soon |
Plasmid DNA services for every stage of development
Quick-turn purifications at a small scale
Larger-scale plasmid service for research
