E. Coli Expression Host Protein Residue Detection Kit (Enzyme-Linked Immunosorbent Assay · One-step Method)

From insulin, recombinant vaccines to GLP-1, EGF/bFGF wound repair proteins, therapeutic antibody fragments, and engineered expression bacteria such as Escherichia coli support the majority of the biopharmaceutical industry chain. However, there may be residual host cell protein (HCP) impurities in biological products. Trace HCP residues not only affect the purity and stability of the product but also may pose an immunogenic risk, directly related to product compliance and medication safety. The residual amount of HCP is a key and essential inspection indicator for drug quality control, process release, and application auditing.
The E. Coli Expression Host Protein Residue Detection Kit (Enzyme-linked immunosorbent Assay - one-step method) can detect the HCP residual protein produced by E. COLI BL21 and W3110 strains in biological products. It also takes into account high sensitivity, high specificity and ease of operation, perfectly meeting the detection needs of all scenarios including process exploration, process quality control and finished product release.

1. High antibody coverage rate
The coverage rate result of AAE-MS was as high as 93.6%.
2. High sensitivity
The detection line is 0.577ng/mL, the linear range is 2-100ng/mL, and the linear correlation is R²> 0.99.

3. The operation is simple and fast
The one-step method system is adopted, and the detection time is less than 2 hours

4. Good specificity

This kit did not detect Pichia coli HCP, CHO HCP, SF9 HCP and MDCK HCP at 1ug/mL, and the spiked recovery rates were all qualified (80%-120%).

5. Core raw materials are self-produced

The key raw materials for core antigens and antibodies are independently produced. The batch differences of the reagent kits are extremely small, and the supply is controllable with better cost performance.

Express the exclusive detection requirements of the system.

Standard curve data display