Significance of Host Cell Protein Residue Detection in Biopharma

Host protein residue detection is an important quality control step in the biopharmaceutical process. In biopharmaceuticals, cell lines (hosts) are typically used to produce proteins or other biological products. These cell lines could be bacteria, yeast, mammalian cells, etc. After the production process is over, the product needs to go through multiple purification steps to remove non-target impurities, one of which is the protein of the host cell. However, the purification process may not completely remove all host proteins, so it is necessary to detect and quantify these residual host proteins.

 

Importance of Host Protein Residue Detection

1. Host proteins may affect the safety and effectiveness of the drug.

2. Certain host proteins may induce an immune response.

3. Regulatory agencies have strict standards that require the amount of host protein residue in biological products to be within a safe range.

 

Host protein residue detection is a critical step in the biopharmaceutical process to ensure product quality and safety. As a reault, highly sensitive and specific methods are required for accurate measurement.