Host Cell Protein (HCP) Content Detection Service

    Host cell proteins (HCP) content analysis, a critical quality control measure, is essential for determining and quantifying the content of HCP in the final product during bioproduct production. Primary techniques for assessing HCP content include immunological methods, notably enzyme-linked immunosorbent assay (ELISA), and mass spectrometry (MS). ELISA can roughly evaluate HCP levels by detecting HCP-specific antigens. Conversely, liquid chromatography-tandem mass spectrometry (LC-MS/MS) provides detailed quantitative results.

     

    HCP content analysis plays a pivotal role in ensuring drug safety and efficacy. Reducing HCP content can decrease drug production risks, enhance quality control, and fulfill regulatory obligations. Moreover, this analysis is invaluable for optimizing drug development and manufacturing processes.

     

    MtoZ Biolabs, which offers specialized HCP analysis services. Utilizing ELISA, known for its high sensitivity and specificity, MtoZ Biolabs accurately quantifies complex biological samples. Additionally, MtoZ Biolabs employs high-resolution LC-MS/MS for comprehensive HCP analysis, supporting various stages of drug development, including early research, clinical trials, and market monitoring across monoclonal antibodies, recombinant proteins, and products of gene therapies. MtoZ Biolabs adheres to global quality standards in all experimental procedures, ensuring the reliability and comparability of data. With a team of experts possessing much research experience, MtoZ Biolabs provides one-stop services from experimental design to data analysis. Free consultation is available!

     

    Deliverables

    1. Experimental Procedures

    2. Relevant Experiment Parameters

    3. Comprehensive HCP Content Analysis

    4. Mass Spectrometry Images

    5. Raw Data

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