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| 品質管理 | Item | Test Method | Specification | RUO Default |
RUO Upgrade |
Preclinical Default |
Preclinical Upgrade |
|---|---|---|---|---|---|---|---|
| Identification | Appearance | Visual Inspect | Clear and free of foreign particles | ||||
| RNA Length | Capillary Electrophoresis | Target ± 30% | |||||
| RNA Length | Agarose Gel Electrophoresis | Expected size band detected | |||||
| Poly A Length | Enzyme digestion and CE | Target ± 30% | |||||
| RNA Content | UV Absorbance | Target ± 5% | |||||
| PH | pH meter | Target ± 0.5 | |||||
| Buffer Specification | Client Spec | N/A | |||||
| Purity | A 260/280 Ratio | UV Spec | 1.70 ~ 2.30 | ||||
| Capping Efficiency | LC-MS | ≥ 90% | |||||
| Size based purity | Capillary Electrophoresis | ≥75% | |||||
| Impurity | Total protein residue | Nano Orange Assay | ≤ 1% | ||||
| Plasmid DNA Residue | qPCR | ≤ 0.05% | |||||
| dsRNA | Slot-blot | ≤ 0.1% | |||||
| Safety | Endotoxin | Semiquantitative | < 10EU/mg | ||||
| Endotoxin | Quantitative | < 10EU/mg | |||||
| Bioburden | Sdirect Inoculation | No Growth after 48 hrs |
注：追加の品質管理および評価をご希望の場合はお問合せください。
mRNA Infographic
IVT mRNAの主要な構造的特徴、機能および、
臨床応用が期待されているIVT mRNAを用いたワクチンの候補、治療におけるmRNAのキャリアーとしての脂質ナノパーティクルなどについて
ワクチン研究におけるmRNA合成サービスプラットフォーム
