Host cell proteins (HCPs) are proteins produced by the organisms used to manufacture biologics. Residual HCPs in a biological drug can affect product quality, efficacy, and patient safety. As a result, measuring the total amount of residual HCP is a critical quality attribute for batch release. HCP assay kits are widely used for this purpose, providing a reliable method to quantify HCP levels in biopharmaceutical products. These kits typically use sandwich immunoassays with polyclonal antibodies to deliver high sensitivity and specificity while maintaining cost-effectiveness and throughput.
Regulatory Considerations for HCP Assay Kits
Regulatory agencies such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH) provide guidelines for monitoring HCPs in biologics. These guidelines emphasize that residual HCP levels must be measured accurately to ensure safety and quality. HCP assay kits must demonstrate appropriate antibody coverage, assay sensitivity, and reproducibility for the specific host cell and product type. Documentation of validation parameters including accuracy, precision, linearity, and specificity is required to meet regulatory expectations. Using kits that follow these standards helps ensure compliance during product development and release.
ExCell Bio’s HCP Assay Kit Solutions
ExCell Bio provides HCP quantitation kits designed to comply with regulatory guidelines and support reliable measurement of residual host cell proteins. These kits combine upstream host cell isolates with polyclonal antibodies in a validated ELISA format, offering robust sensitivity and specificity. ExCell Bio’s HCP assay kits provide quantitative results with high throughput and automation potential, making them suitable for research, development, and production environments. By following regulatory expectations, these kits help manufacturers maintain product safety, efficacy, and consistent quality.
Conclusion
Regulatory guidelines require accurate measurement of residual host cell proteins to ensure the safety and quality of biologics. ExCell Bio‘s HCP assay kits provide validated solutions with high sensitivity and reproducibility, supporting compliance and reliable HCP quantitation. Using these kits helps streamline batch release and maintain consistent product quality across biopharmaceutical applications.
