GMPro™ Plasmid Manufacturing Service
GMPro™ plasmid DNA is produced starting from fully characterized working cell bank and we ensure the stability and quality of the product. The whole process, manufacturing environment and documentation are strictly controlled under comprehensive quality assurance, guarantee the product quality and compliant for early stage clinical trials.
Documentations such as manufacturing summary report, batch record are available for regulatory submissions, to fully support your project.
Expect MORE from GMPro™ Plasmid
Meet Clinical Trials Expectations
(mg to g level)Either quality or accompanied documents to meet your clinical expectations
Full Quality Assurance (QA) control
100 % guarantee during the whole process
Value-added options to exceed your expectations
Additional options available to customize your project
- High-density fermentation
- Alkaline lysis
- Chromatographic purification
- Product release review
- TSE/BSE statement
- Manufacturing Summary Report
- Full quality oversight
Optional:
- E.coli Working Cell Banking
- Stability test
- Additional quality control
More assays are included except for the ones listed below, and other options are available. Get a quote for more information.
| QC Item | QC Method |
|---|---|
| Appearance | Visual inspection |
| A260/A280 | Absorbance ratio |
| Restriction Digest | AGE |
| Supercoiled Content | HPLC |
| Residual E. coli DNA | AGE |
| Residual E. coli RNA | AGE |
| Sequencing | Sanger |
| Endotoxin | LAL assay |
| ...... | ...... |
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