Chinese Hamster Ovary (CHO) cells are a widely used animal cell expression system in the production of biologics, including antibodies, recombinant proteins, and vaccines. During the production and purification of products using these cells, Host Cell Protein (HCP) impurities are inevitably introduced, which can reduce product efficacy and lead to adverse toxicity or immunogenic reactions. Therefore, it is crucial to ensure that the residual HCP level in the final biologic product is as low as possible. The ELISA method is a simple, highly sensitive, and objective method for HCP detection. This kit is based on the double-antibody sandwich enzyme-linked immunosorbent assay principle and utilizes a one-step protocol: Gradient-diluted standards (36730-B) or test samples and diluted detection antibody (36730-C) are sequentially added to microwell plates coated with anti-CHO HCP antibodies. A single incubation step is sufficient to form a "solid-phase antibody-antigen-detection antibody-enzyme conjugate complex." This one-step method simplifies the workflow, shortens incubation time, reduces errors introduced by multiple pipetting steps, and is suitable for high-throughput automated detection. After incubation, washing removes unbound substances. A substrate solution (prepared by mixing Substrate Solution A (36730-G) and Substrate Solution B (36730-H)) is added for color development. The intensity of the color in the sample wells is positively correlated with the CHO HCP content. This kit can be used for optimizing biologic purification processes, controlling impurities in intermediate processes, and release testing of final products. Features Regulatory Compliance: Fully validated in strict accordance with ChP, USP, and ICH Q2(R1). Quality Control: Core raw materials are independently developed, fully traceable, and exhibit minimal batch-to-batch variation. Audit Support: Stable process with comprehensive documentation provided for audits. High Sensitivity: Low limit of quantification (LOQ) down to 3 ng/mL. Strong Specificity: Highly specific with no interference from exogenous proteins. The one-step operation is rapid and convenient, suitable for both CHO-S and CHO-K1 cells. Specifications Cat.No. 36730ES24 / 36730ES96 Size 24 T / 96 T Components Components No. Name 36730ES24 36730ES96 36730-A Anti-CHO coated microtiter strips 24 T 96 T 36730-B Standard: CHO HCP (4.86 μg/mL) 50 μL 200 μL 36730-C Detection Antibody (100×) 50 μL 200 μL 36730-D Dilution Buffer 1 3.75 mL 15 mL 36730-E Dilution Buffer 2 7.5 mL 30 mL 36730-F Wash Buffer Concentrate(20×) 7.5 mL 30 mL 36730-G Substrate Solution A 2 mL 8 mL 36730-H Substrate Solution B 2 mL 8 mL 36730-I Stop Solution 3.75 mL 15 mL 36730-J Plate Sealer 1 each 3 each Storage Store at 2~8°C. Valid for 1 year.[Note]: *After receiving the goods, please check whether all components are complete and immediately store them at the corresponding temperature. Documents: Safety Data Sheet 36730_MSDS_HB260422_EN.PDF Manuals 36730_Manual_Ver.EN20250422.pdf
