Preclinical Plasmid DNA
Bridging Discovery to IND-Readiness with Confidence.
Key Benefits
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Comprehensive quality control of supercoil content and endotoxin levels
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Quantitative impurity analysis
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Animal- free production is available
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Guaranteed quantity of mg to gram with material archiving option
Service Details
Production details
| PackGene plasmid process | Preclinical |
|---|---|
| Clone screening | √ |
| Growth condition optimization | √ |
| High density fermentation | √ |
| Alkaline lysis | √ |
| Chromatographic purification | √ |
| Antibiotics free | √ |
| Consistent manufacturing process | √ |
| Instrument calibration/validation | Calibration |
| COA & CoC | COA |
| TSE/BSE | O |
| Antibiotics Free Production | √ |
| Animal Free Production* | O |
| Material Archiving | Plasmid archived, additional charges for bacteria |
Quality Control
| Test | Methods |
|---|---|
| Appearance | Visual inspection |
| A260:280 | Ultraviolet-visible spectrophotometry (A260/A280) |
| Homogeneity | HPLC |
| Restriction Analysis | Agarose gel |
| Residual RNA | SYBRGold |
| Residual E. coli DNA | qPCR |
| Endotoxin | LAL |
| Bioburden Testing | Direct inoculation |
| Sequencing | Sanger |
| Residual Host Protein | HCP ELISA |
| Mycoplasma Contamination | qPCR |
| pH | Potentiometry |
| Residual Kanamycin | ELISA |
| Sterility | |
| Osmolality |
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Confidentiality Commitment from PackGene:
The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.