This kit utilizes the ELISA (Enzyme-Linked Immunosorbent Assay) method for the quantitative detection of Host Cell Proteins (HCP) in biological products that are expressed and amplified using E. coli.
Host Cell Proteins are residual impurities that may remain from the production process and pose a risk to the safety and efficacy of biological products. The ELISA method provides a sensitive, specific, and reliable solution for detecting and quantifying these residual proteins, ensuring compliance with regulatory standards and maintaining product quality.
This kit is particularly useful in the quality control and safety testing of biopharmaceuticals derived from E. coli expression systems.
* This kit is for research use only and is not intended for medical diagnostic purposes.
Product Features:
1. Specificity: No cross-reactivity with host cells such as CHO or Pichia pastoris.
2. Reproducibility: Intra-assay variation coefficient <10%, inter-assay variation coefficient <15%.
3. Sensitivity: Limit of detection (LOD) is 1.5 ng/mL.
4. Accuracy: Recovery rate of spiked samples is between 80% and 120%.
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