Expression of viral vectors and vaccines in Vero cells is a cost-effective method for production of commercial quantities of a drug substance. The manufacturing and purification process of these products leaves the potential for impurities by HCPs from Vero cells. Such impurities can reduce the efficacy of the therapeutic or vaccine agent and result in adverse toxic or immunological reactions. Thus, it is desirable to reduce HCP impurities to the lowest levels practical.
This kit was developed using the antibodies that have been generated against and affinity purified using mild lysate of Vero cells. This simple to use, robust, and semi-quantitative ELISA is a sensitive and specific method to aid in optimal purification process development, process control, routine quality control, and product release testing. This kit is “generic” in the sense that it is intended to react with a majority of the HCPs that could pollute the product independent of the purification process.
This Vero Cell HCP ELISA has an LOD of ~1.4 ng/ml.

描述
在 Vero 细胞中表达病毒载体和疫苗是生产商业量药物的一种经济有效的方法。这些产品的制造和纯化过程留下了来自 Vero 细胞的 HCP 产生杂质的可能性。此类杂质会降低治疗剂或疫苗剂的功效并导致不利的毒性或免疫反应。因此，希望将 HCP 杂质减少到实际的最低水平。
该试剂盒是使用针对 Vero 细胞的温和裂解物产生并亲和纯化的抗体开发的。这种简单易用、稳健且半定量的 ELISA 是一种灵敏且特异的方法，有助于优化纯化工艺开发、工艺控制、常规质量控制和产品放行测试。该试剂盒是“通用的”，因为它旨在与大多数可能污染产品的 HCP 反应，而与纯化过程无关。
此 Vero Cell HCP ELISA 的 LOD 约为 1.4 ng/ml。