mRNA-LNP成品的品質控制對於mRNA疫苗和藥物的有效性至關重要。我們已針對mRNA原液、LNP製劑進行了多種檢測項的分析方法開發與驗證，可提供多種檢測服務，滿足客戶對於早期研發、mRNA疫苗藥物申報及臨床樣品製備等多種檢測需求。
QC Detection Items of mRNA
| Option | Items | Test Method |
| 1 | Appearance | Visual inspection |
| 2 | Concentration | Ultraviolet spectroscopy (UV) |
| 3 | Purity | Ultraviolet spectroscopy (UV) |
| 4 | Intactness | Capillary electrophoresis（CE） |
| 5 | Sequence length | Agarose gel electrophoresis（AGE） Capillary electrophoresis（CE） |
| 6 | Endotoxin | Gel-clot technique |
| 7 | pH | Electrode method |
| 8 | Total protein residues | Nanoorange® Protein quantitation kit |
| 9 | 5′ Capping rate | Reverse-phase ion-pairing liquid chromatography mass spectroscopy (RP–IP–LC-MS) |
| 10 | 3′ poly(A) tail length | Reverse-phase ion-pairing liquid chromatography mass spectroscopy (RP–IP–LC-MS) |
| 11 | Residual DNA template | Quantitative PCR (qPCR) |
| 12 | mRNA sequence identity confirmation | Sanger sequencing |
| 13 | RNase residues | Agarose gel electrophoresis（AGE）/ Quantitative PCR (qPCR) |
| 14 | dsRNA residues | Enzyme-linked immunosorbent assay (ELISA) |
| 15 | NTPs residues | Size exclusion chromatography（SEC） |
| 16 | T7 RNA Polymerase residues | Enzyme-linked immunosorbent assay (ELISA) |
| 17 | Aggregate quantitation | Size exclusion chromatography（SEC） |
| 18 | Expression of target protein | Cell-based assay |
| 19 | Sterility testing | Direct inoculation |
QC Detection Items of mRNA-LNP
| Option | Items | Test Method |
| 1 | Appearance | Visual inspection |
| 2 | LNP size | Dynamic light scattering (DLS) |
| 3 | Polydispersity | Dynamic light scattering (DLS) |
| 4 | Zeta potential | Phase analysis light scattering (PALS) |
| 5 | Encapsulation efficiency | Fluorescence-based assay |
| 6 | mRNA concentration | Fluorescence-based assay |
| 7 | pH | Electrode method |
| 8 | Endotoxin | LAL gel method |
| 9 | mRNA integrity | Capillary electrophoresis（CE） |
| 10 | 5′ Capping rate | Reverse-phaseion-pairing liquid chromatography mass spectroscopy (RP–IP–LC-MS) |
| 11 | Residual solvents | Gas chromatography（GC） |
| 12 | mRNA sequence identity confirmation | Sanger sequencing |
| 13 | Expression of target protein | Cell-based assay |
| 14 | Sterility testing | Direct inoculation |
檢測平台（儀器展示）
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