ELISA Kits
Host Cell Protein ELISA Kits
Mammalian HCP ELISA Kits
CHO HCP ELISA Kit, 3G
Description
This CHO HCP 3rd Generation ELISA Kit, Item Number F550-1 will be replacing the current CHO HCP ELISA Kit, 3G, Item Number F550. Cygnus has manufactured, characterized, and qualified large pools of the new reagents that will replace the current reagents. The antibodies were developed and purified in the same way as the original critical reagents in the F550 Kit. The coverage of the new antibodies to the CHO HCP antigen from CHO-S and CHO-K1 strains was determined to be ~86% by Antibody Affinity Extraction which is not significantly different from the current antibodies in the F550 kit. More importantly, Cygnus Technologies has demonstrated the equivalency of the new antibodies (3G-0016-1-AF) in the 3G CHO ELISA (F550-1) using a panel of CHO samples from a number of independent biomanufacturing processes. Similar to the F550 “CHO 3G” ELISA, the F550-1 “CHO 3G” ELISA is more sensitive than previous kits, able to detect HCPs in the range of 100 parts per billion for a variety of antibodies and other therapeutic proteins expressed in CHO. This data indicates the kit is truly a generic method that can likely be validated as not only a process development tool, but in most cases as a lot release test, eliminating the need to develop a custom or process specific assay. This new Cygnus Technologies’ CHO HCP ELISA Kit, 3G provides the specificity and sensitivity (LOD ~0.3 ng/ml, LLOQ ~1 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance. Please use Sample Diluent, Item No. I028, with these kits; available separately.
此 CHO HCP 第三代 ELISA 试剂盒,产品编号 F550-1 将取代当前的 CHO HCP ELISA 试剂盒,3G,产品编号 F550。 Cygnus 已经制造、表征和鉴定了大量新试剂,这些新试剂将取代现有试剂。抗体的开发和纯化方法与 F550 试剂盒中的原始关键试剂相同。来自 CHO-S 和 CHO-K1 菌株的 CHO HCP 抗原的新抗体的覆盖率通过抗体亲和提取确定为约 86%,这与 F550 试剂盒中的当前抗体没有显着差异。更重要的是,Cygnus Technologies 使用来自多个独立生物制造过程的一组 CHO 样本证明了新抗体 (3G-0016-1-AF) 在 3G CHO ELISA (F550-1) 中的等效性。与 F550 “CHO 3G” ELISA 相似,F550-1 “CHO 3G” ELISA 比以前的试剂盒更灵敏,能够检测 CHO 中表达的各种抗体和其他治疗性蛋白的十亿分之 100 范围内的 HCP .该数据表明该试剂盒确实是一种通用方法,不仅可以作为工艺开发工具进行验证,而且在大多数情况下可以作为批次放行测试,从而消除了开发定制或工艺特定分析的需要。这种新的 Cygnus Technologies 的 CHO HCP ELISA 试剂盒 3G 提供了检测 HCP 的特异性和灵敏度(LOD ~0.3 ng/ml,LLOQ ~1 ng/ml),具有支持法规遵从性的重现性。请在这些套件中使用样品稀释剂,货号 I028;可单独购买。
Important Change Notification Memo: CHO HCP ELISA Kit, 3G Resupply
重要变更通知备忘录:CHO HCP ELISA 试剂盒、3G 补给
Product Information
Product Insert
F550-1 PI CHO 3G Resupply ELISA
Kit Components
Product FAQs
- Can the ELISA Protocol in the Product Insert be Modified?
- Calibration of HCP assays
- How do I Maintain Quality Control of ELISA?
- What About Automation of Immunoassays?
- What is the Storage and Stability of ELISA Kits?
- What Issues to Consider When Diluting Samples?
- Which Cygnus CHO HCP kit to use: F015, CM015, F550 or F550-1?
- Why Perform Dual Wavelength Analysis?
Related
Catalog #: D550T
Catalog #: D550W
Catalog #: D555T
Catalog #: D555W
Catalog #: I028