- 產品特點
- 產品資訊
- 產品規格
- 技術文件
1. 超高載量：經條件優化每毫升填料載量可達 9 x 10^9 TU。
2. 超高流速：操作流速可設定5 ~ 10 CV/分鐘。
3. 低鹽洗脫：相較於市售陰離子膜層析填料，可使用較低鹽濃度的溶液進行洗脫，減少高鹽環境對慢病毒結構的損害。
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. 雜質去除：可去除超過 95%以上的宿主蛋白 (HCP) 與雙股DNA (dsDNA) 之不純物。
6. 超低背壓：正常操作下管柱背壓遠小於1 Bar。
7. 重複使用：使用 0.5M NaOH執行CIP，重複多次後捕獲效能不受影響。
8. 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。
9. 文件齊全：提供完整Regulatory Support File (RSF)。
10. 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 |
Weak anion exchange |
|
Typical dynamic binding capacity |
BSA: > 60 mg/mL |
|
Maximum pressure at 20ºC |
6 Bar | 0.6 MPa | 87 psi |
|
Bed volume (BV) |
1 mL; 10 mL; 100 mL |
|
Normal void volume |
3.5 mL; 30 mL; 300 mL |
|
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, 1 M acetic acid, 1 M NaOH, and solutions containing up to 10 mM EDTA |
|
Connections |
1mL ➡ Luer |
|
Vent valve |
Screw cap |
|
Repeat use |
Single batch use |
|
Materials of construction |
Housing: Polypropylene, Silicone |
|
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 |
|
Nereus LentiHERO |
NL100100 |
|
LentiHERO® 1 (1mL) |
LH0001001A |
|
LentiHERO® 10 (10mL) |
LH0001001B |
|
LentiHERO® 100 (100mL) |
LH0001001C |
