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基本描述
| 规格或纯度 | 医药级 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 英文名称 | T7 RNA Polymerase | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 单位定义 | 在 37℃、pH8.0 的条件下，1 小时内使 1nmol 的 [3H] GMP 掺入酸不溶性沉淀物所需要的酶量定义为 1 个活性单位。 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 储存温度 | -20°C储存 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 运输条件 | 超低温冰袋运输 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 产品介绍 |
产品描述 T7启动子是目前转录效率最高的一类启动子，因此采用T7 RNA聚合酶进行体外转录可获得更多的合成产物，T7 RNA聚合酶也是综合性能最好的RNA聚合酶，可实现大规模工业化RNA生产。 T7 RNA Polymerase（T7 RNA聚合酶） 为噬菌体 T7 DNA编码的酶，是一种高度特异识别 T7启动子序列的 DNA依赖的 5'→3' RNA聚合酶，以含有聚合酶，以含有 T7启动子序列的单链或双DNA为模板，以为模板，以 NTP为底物，合成与启动子下游的单链为底物，合成与启动子下游的单链 DNA互补的 RNA。T7 RNA聚合酶是体外转录生产治疗用 mRNA的关键酶。 本制品为利用大肠杆菌规模发酵表达的 GMP级重组 T7 RNA 聚合酶 ，采用药规格原辅料生产并严控制宿主蛋白质残留、核酸残留等，符合 GMP规范的产品生与质量管理程保障过及所有原辅料可追溯。? 质量要求
遵循以下规范生产 1. ISO 9001:2015, certified facility。 2. 《GMP附录 -细胞治疗产品》国家药监督管理局。 细胞治疗产品》国家药监督管理局。 3. 《人用基因治疗总论 -中国药典 2020》国家药典委。 4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products用于细胞治疗，基因和组织工程 用于细胞治疗，基因和组织工程 产品中的辅料 。 5. USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing 细胞治疗产品生过程中因子和 细胞治疗产品生过程中因子和 生长因子 。 6. Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products用于生产细胞或基因治疗药物的来源原料。? 产品特点 对于 T7 启动子有高度的特异性，用于体外 RNA（含小 RNA）的合成。? 产品用途 1. 合成单链 RNA。? 2. 合成高特异性 RNA 探针。? 3. 合成 siRNA 前体。 4. 制作 RNA 剪接反应（RNA splicing）的前体。5. 利用帽类似物合成带帽 RNA。 保存体系 100 mM NaCl; 50 mM Tris-HCl (pH 7.9); 1 mM EDTA; 20 mM 2-mercaptoethanol; 0.1% Triton X-100; 50% (v/v) Glycerol。? 注意事项 1. 为了特定区域的有效转录，建议在其区域下游把模板 DNA 预先切成平端或 5′突出末端。 2. 缓冲液中的亚精胺与核酸结合可能形成不溶物，建议最后加入模板 DNA。 Product Description T7 promoters are currently the most efficient type of promoters. Therefore, T7 RNA polymerase can be used for in vitro transcription to obtain more synthetic products. T7 RNA polymerase is also the RNA polymerase with the best comprehensive performance, which can realize large-scale industrialization. RNA production. T7 RNA Polymerase (T7 RNA polymerase) is an enzyme encoded by bacteriophage T7 DNA. It is a DNA-dependent 5'→3' RNA polymerase that highly specifically recognizes the T7 promoter sequence. It contains polymerase and contains T7 promoter. The single-stranded or double-stranded DNA of the sequence is used as the template, and NTP is used as the substrate to synthesize the single-stranded downstream of the promoter as the substrate, and synthesize RNA that is complementary to the single-stranded DNA downstream of the promoter. T7 RNA polymerase is a key enzyme for in vitro transcription and production of therapeutic mRNA. This product is a GMP-grade recombinant T7 RNA polymerase expressed by E. coli large-scale fermentation. It is produced with raw materials of pharmaceutical specifications and strictly controlled host protein residues and nucleic acid residues. Product production and quality management procedures that meet GMP specifications have been guaranteed and all original The accessories are traceable. Quality requirements
Follow the following specifications for production 1. ISO 9001:2015, certified facility. 2. "GMP Appendix-Cell Therapy Products" State Drug Administration. Cell Therapy Products" State Drug Administration. 3. "General Introduction to Human Gene Therapy-Chinese Pharmacopoeia 2020" National Pharmacopoeia Commission. 4. USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products are used as excipients in cell therapy, gene and tissue engineering products. 5. USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing 6. Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products. Features It has a high degree of specificity for the T7 promoter and is used for the synthesis of RNA (including small RNA) in vitro. Product Usage 1. Synthesize single-stranded RNA. 2. Synthesize highly specific RNA probes. 3. Synthesize siRNA precursor. 4. Make the precursor of RNA splicing reaction (RNA splicing). 5. Use cap analogs to synthesize capped RNA. Preservation system 100 mM NaCl; 50 mM Tris-HCl (pH 7.9); 1 mM EDTA; 20 mM 2-mercaptoethanol; 0.1% Triton X-100; 50% (v/v) Glycerol. Precautions 1. In order to effectively transcribe a specific region, it is recommended to cut the template DNA into blunt ends or 5'overhanging ends in advance in the downstream of the region. 2. Spermidine in the buffer may combine with nucleic acid to form insoluble matter. It is recommended to add template DNA at the end. |
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