Our INDReady® Program is designed to meet the requirements for cGMP intermediates. INDReady® Plasmid DNA is produced so that all processing components used are dedicated for single plasmid use or are disposable. All components used are animal free or are treated in compliance with appropriate regulations to reduce the risk of TSE/BSE contamination. These contracts have a dedicated scientist and are processed in dedicated rooms. The processing utilizes our proprietary resin, PolyFlo® (DMF13090) and results in highly pure DNA meeting the specifications detailed below. A Manufacturing Summary of all documentation can be provided and is suitable for IND submission.
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 @ 1.0ug load |
| ssDNA, Linear DNA, Chromosomal DNA | None Detected @ 1.0ug load |
| Protein | Reported |
| pH of Final Product | 7.5-8.5 |
| Endotoxin | <30 EU/mg |
| Identity | Information for 2 Restriction Reactions |
| Five Day Bioburden | No growth on plates |
| Bottling | Collaborator Defined |
