SHENTEK® HCP ELSA kits are intended for biologics-host cell protein quantitation analysis, and they cover a wide range of regularly used cell lines, including bacteria, insect, mammalian, and human host cells. Host cell proteins (HCPs) are key class of process-related impurities,and regulatory requirements call or HCP levels to bekept as low as feasible. Each SHENTEK® assay has been validated with process-specific performance and has been developed by immunizing with high and low molecular weight protein fractions, resulting in improved detection of small proteins. Furthermore, SHENTEK® HCP antigen is created as a good representation of the product-or process-specific cell harvest sample, containing the majority of HCPs that could potentially end up in the final product. SHENTEK® produces a sufficient amount of antibody to avoid potential bridging studies and re-validation of GMP release tests.
Assay type: Sandwich ELISA format
Linear range: Refer to the specific cell line, R²>0.990
Limit of quantitation (LOQ): 1-10 ng/mL
Precision (Repeatability): CV<15%
Accuracy: 80%≤Recovery≤120%
Specificity: No cross-reactivity with host cell proteins from different species
Robustness: Consistent assay performance across different sample matrices, and consistent sample linearity throughout a dilution series.
Coverage: Risk factors of immunogenicity: High-risk and process-specific HCPs are covered in ELISA standards and antibodies.
Coverage assessment: Coverage of the HCP antibodies to the standards was validated by orthogonal methods of IMBSO-2D&MS.
Stability: Highly consistent product quality within and between batches for reliable QC results.
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