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T7 RNA Polymerase, GMP grade DMF Filed
产品描述（Product Description）
T7 RNA Polymerase 为大肠杆菌重组表达的噬菌体 T7 DNA 编码的蛋白，是一种高度特异性识别 T7 启动子序列 (5'-TAATACGACTCACTATAG-3') 的 DNA 依赖的 5'→3' RNA 聚合酶。本品以含有 T7 启动子序列的单链或双链 DNA 为模板，以 NTP 为底物，合成与启动子下游的单链 DNA 或双链 DNA 模板链互补的 RNA 链。
本产品是基于公司独特的创新型功能重组蛋白生产平台 SAMSTM 设计，经过大肠杆菌表达体系与纯化工艺的优化，并按照 GMP 要求生产。主要参与mRNA疫苗生产过程中的体外转录。目前，该产品已完成 FDA DMF 备案，备案编号为 037660，加速药物申报进程。
产品信息（Product Info）
|
产品名称 (Product Name) |
T7 RNA Polymerase |
|
产品性状 (Product Characters) |
溶液澄清，无悬浊物，无沉淀或杂质 |
|
表达系统（Source） |
E.coli |
|
运输/保存条件（Transportation/Storage Condition） |
干冰运输，-20 ± 5℃保存，避免反复冻融 |
质量标准 (Quality Requirement)
可见异物符合要求
鉴别符合要求
活性 ≥ 50.0 kU/ml
纯度 ≥ 95.0%
DNA酶残留阴性
RNA酶残留阴性
蛋白酶残留阴性
重金属残留 ≤ 10.0 ppm
镍盐残留 ≤ 10.0 ppm
细菌内毒素 ≤ 10.0 EU/ml
宿主DNA残留 ≤ 100.0 pg/mg
宿主蛋白残留 ≤ 20.0 ng/mg
微生物限度 ≤ 1 CFU/10 ml
pH 7.9 ± 0.5
产品规格 (Specifications)
| 编号 | 产品组分 | 产品货号 | 包装规格 |
|---|---|---|---|
| GMP-T7P-EE101-1 MU | T7 RNA Polymerase | GMP-T7P-EE101-12 | 50 U/μl, 1 MU, 20 ml/vial |
| 5×Transcription Buffer-1 | GMP-T7P-EE101-32 | 60 ml/vial |
产品数据（Assay Data）
Efficient transcription of mRNA of different lengths
Three plasmids (lane 1 with poly A tail, lane 2 and 3 without poly A tail) were used as templates, and the reaction was performed for 2 h at 37°C in a 20 μl system. The transcription length were 2000 nt, 4000 nt and 2000 nt, respectively. The above mRNA was not purified.
Three batches of activity testing
Detection of T7 RNA Polymerase by probe. The detection principle is that when the probe and transcript specifically bind, the conformation changes and the fluorescence intensity changes. Three batches of T7 RNA Polymerase were detected, and the slope was similar across all batches, indicating stable activity across batches.
Excellent purity&yield compared to competitors
Yield were assessed via nanodrop and Agilent 4150, and purity was assessed by CE. Overall, yield and purity of Kactus T7 RNA Polymerase was comparable to competitors.
注意事项（Cautions）
(1) 为了避免蛋白及盐离子等对体系的影响，质粒线性化后建议纯化后再作为模板进行体外转录。
(2) DNA 模板预先切成平端或 5' 突出末端有利于特定区域的有效转录。
(3) 低温会导致 5×Transcription Buffer-1 中的亚精胺沉淀 DNA 模板，建议室温下配制反应体系。
