Analysis of Peptide Drugs: HCP and HCD

Peptide drugs are bioactive molecules made up of multiple amino acids linked by peptide bonds. Typically, it consists of 10 to 100 amino acids and has a relative molecular mass below 10,000. Most peptide drugs are derived from endogenous peptides or natural peptides, so they have little or no side effects on the human body. Compared to protein drugs, peptide drugs also have advantages such as good stability, high purity, low production cost, and low immunogenicity. With the rapid development and maturation of peptide synthesis technology, peptide drugs have become the focus of biopharmaceutical research in recent years.

 

Host cell proteins (HCP) and host cell DNA (HCD) are common impurities in the process of peptide drug production. If their content exceeds a certain level, it may cause immune reactions or other adverse reactions. For example, HCP contains some protein hydrolase enzymes, which may cause the target protein to be fragmented and lose its activity. HCD residue has a certain carcinogenicity and risk, and even has the potential risk of causing tumors. Therefore, the detection of HCP and HCD residues is the most common analysis project in the research and quality control of antibody drugs, and it is crucial for monitoring the safety and quality controllability of peptide drugs.

 

At present, commonly used methods for HCP detection mainly include enzyme-linked immunosorbent assay (ELISA), 1D/2D-PAGE, and mass spectrometry (MS) based analysis techniques. ELISA uses polyclonal antibodies to quantitatively analyze the overall abundance of HCP, but it is generally not possible to quickly quantify individual HCP components using this method, and HCP with weak immunogenicity or non-immunogenicity may not be detected. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) can identify and quantify HCP impurities at the same time. It is the main complementary analysis method to ELISA, and it is also the mainstream method for HCP identification.

 

MtoZ Biolabs provides customers with drug quality research services that comply with global pharmaceutical regulations. We provide peptide drug HCP and HCD analysis services based on our existing testing platform. We have experienced technical personnel who can provide you with a full set of professional services, including experimental design, sample testing, and data analysis. We can accurately detect possible residual host proteins and residual host DNA in peptide drugs. Feel free to consult.