HCP Host Protein Residue

Host cell proteins (HCP) refer to the protein components from the host cells of the production cell line in biological products, which mainly include the structural proteins and secretory proteins of the host cells. These proteins are diverse and their physical and chemical properties, such as isoelectric point, hydrophobicity, relative molecular weight, etc., often have significant differences. As non-target components in biological products, HCP may bring some potential hazards:

 

1. Immunogenicity

HCP residues may be recognized as foreign substances by the human immune system, leading to an immune response. This may cause allergic reactions or reduce the efficacy of biopharmaceuticals.

 

2. Safety Issues

Some HCPs may have unknown biological activity or toxicity. If these residual proteins are not fully removed in the pharmaceutical process, they may pose a threat to patient safety.

 

3. Drug Stability

Residual host proteins may affect the stability and quality of biopharmaceuticals, leading to drug degradation or denaturation, thereby reducing their effectiveness.

 

4. Regulatory Compliance

In some countries and regions, regulatory agencies have strict restrictions on the content of host protein residues. If the host protein residues in biological pharmaceutical products exceed the specified limit, it may lead to legal issues for manufacturers and affect the product's market introduction and sales. For example, the US Pharmacopoeia stipulates that the range of HCP residues is 1-100 ng/mg.

 

Highly sensitive and repeatable host protein detection methods are not only key to ensuring the safety and effectiveness of biological products, but also important parameters for production process control and process optimization. At present, the main methods for detecting HCP are ELISA, SDS-PAGE silver staining, HPLC, capillary electrophoresis, mass spectrometry, etc. These methods all have certain advantages and disadvantages.

 

MtoZ Biolabs, relying on high-precision UV-Visible spectrophotometers and based on the principles of enzyme-linked immunosorbent assays, has developed a host protein residue ELISA analysis platform. MtoZ Biolabs can efficiently and accurately carry out qualitative and quantitative analysis of host protein residues, and is widely used in the quality and safety testing of a variety of biological products. Free project evaluation!