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HCP Content Detection

Host Cell Protein (HCP) content detection is used to determine and quantify the amount of host cell proteins that may remain in the final product during the production process. It is a critical quality control step in biopharmaceutical production. The main methods for HCP content detection include immunological methods (such as Enzyme-Linked Immunosorbent Assay, ELISA) and mass spectrometry techniques. ELISA can provide a preliminary assessment of HCP content by identifying and quantifying specific HCP antigens. Mass spectrometry, particularly Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), can provide more precise quantitative results.

The primary value of HCP content detection lies in ensuring the safety and efficacy of medicines. Reducing HCP content can lower the risks in the drug production process, enhance drug quality control, and meet regulatory requirements. Additionally, HCP content detection can provide important data support for the optimization of drug development and production processes.

ELISA method for HCP content detection

BioTech Pack (BTP)(BTP)has been certified by both CNAS and ISO9001 quality systems; the companyfor HCP content detectionhas developeda specialized service platform,ourELISA technology, with its high sensitivity and specificity, canachieveaccurate quantification ofcomplex samples. In addition, we also usehigh-resolutionLC-MS/MS technology for more in-depth HCP analysis.Whether inearly drug development,clinical trials,ormarket regulation;whether it's monoclonal antibodies, recombinant proteins, or gene therapy products, BTP can provide precise HCP content detection solutions. Our experimental processes strictly adhere to internationally recognized quality standards, ensuring the reliability and comparability of the data. BTP's expert team has many years of experimental experience and rich data interpretation capability, providing you with one-stop services from experimental design to result analysis. Feel free to consult us for free!Bilingual Project ReportsIn technical reports, BioTech Pack will provide you with detailed bilingual (Chinese and English) technical reports, including:

1. Experimental procedures (Chinese and English)

2. Related mass spectrometry parameters (Chinese and English)

3. Detailed information on HCP content detection
4. Mass spectrometry images
5. Raw data

HCP content detection

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