| QC Items | Analytical Method | Specification | |
|---|---|---|---|
| Default QC Items | Appearance | Visual inspection | Clear, colorless, no visible particulates |
| A260:280 | Nanodrop UV absorption | 1.8-2.0 | |
| Identity | Sequence verification of full gene insert | 100% alignment with reference sequence | |
| pH | pH meter | 8.0±0.5 (in TE buffer) | |
| Restriction Analysis | Enzyme digestion and electrophoresis | Conforming to reference pattern | |
| Homogeneity | Agarose gel electrophoresis | ≥ 90% supercoiled | |
| Endotoxin | Quantitative LAL assay | ≤ 0.01 EU/μg | |
| Residual E. coli DNA | Quantitative PCR | ≤ 5% | |
| Residual RNA | Agarose gel electrophoresis | Non-detectable at 200ng | |
| Residual Host Protein | HCP ELISA | ≤ 1% | |
| Bioburden Testing | Direct incubation | No growth on agar plate after 48 hours | |
| Add-On QC Items | Advanced Endotoxin Removal | Quantitative LAL assay | ≤ 0.005 EU/μg |
| Mycoplasma Contamination | Luminescence detection kits | Negative | |
| Detection of Kanamycin | ELISA | ＜1.125 ng/ml |
