- 產品特點
- 產品資訊
- 產品規格
- 技術文件
1. 應用範圍：適用於小型質粒 (~ 4 kb) 與大型質粒DNA (~ 34 kb) 的分離純化。
2. 超高載量：經條件優化每毫升填料載量可捕獲約4mg 質粒DNA。
3. 超高流速：操作流速可設定5 ~ 10 CV/分鐘。
4. 超低剪力：基架採用放射型流道設計，與市售膜層析填料相比大幅降低流道堵塞 (Dead end channel) 風險。
5. 超高純度：超螺旋質粒DNA (Supercolied pDNA) 純度可提升至 95%以上。
6. 雜質去除：可大幅去除Host cell DNA、HCP以及內毒素 (Endotoxin)，不純物殘留量遠低於FDA允收標準。
7. 超低背壓：正常操作下管柱背壓遠小於1 Bar。
8. 重複使用：使用1M NaOH執行CIP，重複數十次後回收率仍可維持約 90%。
9. 製程放大：產品專為實驗室開發到GMP商業化生產所設計，符合線性放大標準。
10. 文件齊全：提供完整Regulatory Support File (RSF)。
11. 符合規範：產品生產符合GMP製造規範，且所有組件皆為USP Class VI並於潔淨室內組裝完畢。
|
產品特性 |
描述 |
|
Ligand |
Hydrophobic interaction chromatography |
|
Maximum pressure at 20ºC |
6 Bar | 0.6 MPa | 87 psi |
|
Bed volume (BV) |
1mL；10mL；100mL |
|
Nominal void volume |
3.5mL；30mL；300mL |
|
Recommended operational flow rate (mL/min) |
5 – 10 CV/min |
|
Recommended pre-capsule pressure |
3 Bar | 0.3 MPa | 43 psi |
|
Chemical stability |
Compatible with buffers commonly used in bioprocessing, including 20% EtOH, 1M acetic acid, 1M NaOH, and solutions containing up to 10mM EDTA |
|
Connections |
1mL ➡ Luer |
|
Vent valve |
Screw cap |
|
Repeated use |
Single batch use |
|
Materials of construction |
HOUSING: Polypropylene, Silicone Functional membrane: modified cellulose acetate |
|
Compliance of materials |
All wetted parts have been assessed for low toxicity compliance and bio-compatibility against either USP VI <88>, ISO 10993, 21CFR Part 177 or by risk assessment |
|
Declarations of suitability |
TSE/BSE free, Non-Animal derived, Nitrosamine free statements available |
|
Quality |
Manufactured within an ISO 9001:2015 Quality Management System the product is controlled, traceable and released through the Quality function. For research use only. |
|
產品名稱 |
產品貨號 |
|
pDNAHERO® 1 (1 mL) |
PHP0001001A |
|
pDNAHERO® 10 (10 mL) |
PHP0001001B |
|
pDNAHERO® 100 (100 mL) |
PHP0001001C |
