E. coli Host Cell Protein (High Sensitivity) ELISA Kit

• One-step simultaneous sandwich format — samples and HRP-conjugated detection antibody added concurrently; reduces procedural steps and variability
• 98% antibody coverage by 4D-DIA LC-MS (2,417/2,466 E. coli proteins captured)
• All 19 priority high-risk HCPs detected, including: SlyD · DnaK · GroEL · Trigger Factor · OmpA · OmpC · OmpF · Flagellin
• ICH Q2(R2) 2023 method validation report available upon request

The E. coli Host Cell Protein (High Sensitivity) ELISA Kit is a quantitative sandwich immunoassay for measuring residual E. coli host cell protein (HCP) impurities in biologics manufactured by recombinant expression in E. coli. Designed for use in process development, manufacturing process control, and product release testing, the kit employs a one-step simultaneous sandwich format in which samples and HRP-conjugated polyclonal detection antibody are added concurrently — reducing assay time to just 2 hours 30 minutes.

Method validation as per ICH Q2(R2) 2023 guidelines. The method validation report is available upon request. Suitable for Research and Manufacturing Use.

Biologics produced using host cells can contain residual host cell proteins (HCPs) that must be removed during downstream purification. These process-related impurities can affect product quality through immunogenicity, product instability, or enzymatic activity, making reliable HCP monitoring essential. ENZ-KIT267 uses rabbit polyclonal antibodies raised against E. coli HCPs to provide broad detection of residual host cell proteins, supporting reliable HCP monitoring throughout process development and manufacturing.