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Residual host cell proteins (HCPs) are unavoidable in biopharmaceuticals. They can be immunogenic, exhibit drug-modifying activity, and co-purify at high levels, which may pose a safety risk. To ensure patient safety and product efficacy during manufacturing, regulatory guidance recommends using orthogonal analytical technologies to confirm and supplement HPC ELISA data while mitigating the risk of using a single technology.
Each assay is performed with the same rigor and attention to detail by accomplished CellCarta scientists and bioinformaticians. HCP Detect™ uses proven, state-of-the-art mass spectrometry platforms to provide comprehensive, sensitive, and specific characterization of HCPs in your Drug Substance (DS) or Drug Product (DP). Each HCP analysis is conducted using highly controlled, robust, and documented processes.
Applications:
Comprehensive list of all HCPs and their respective abundance
Absolute quantification of specific HCPs