Recombinant Protein Drug Process Impurity Analysis

Recombinant protein drugs are produced using bioengineering technology, a process that may introduce certain process impurities. These impurities include host cell proteins (HCP), host cell DNA (HCD), protein A, and some substances added during production, such as defoaming agents. These impurities may affect the safety, stability, and biological activity of the drug. Therefore, effective control and accurate analysis of these process impurities are essential components of quality control for recombinant protein drugs.

 

Different impurities produced during the manufacturing process require different analytical methods. For the analysis of host cell proteins (HCP) and protein A, the commonly used method is ELISA (Enzyme-linked immunosorbent assay), which uses specific antibodies for detection to accurately measure their concentrations. In addition, mass spectrometry can also be used for the detection of HCP and protein A, which can help identify specific types of HCP and quantify their relative abundance. Host cell DNA (HCD) is usually analyzed using PCR (Polymerase Chain Reaction) and titer method, where PCR can specifically amplify DNA for its detection, and the titer method can evaluate HCD residue by measuring the total amount of DNA in the sample. Analysis of defoaming agents usually requires HPLC or gas chromatography (GC). These methods can provide detailed information about the types and concentrations of defoaming agents, thereby helping us evaluate their residue in recombinant protein drugs.

 

MtoZ Biolabs provides drug quality research services that comply with global pharmaceutical regulations. We use Thermo Fisher's Q ExactiveHF mass spectrometry platform, Orbitrap Fusion mass spectrometry platform, Orbitrap Fusion Lumos mass spectrometry platform combined with Nano-LC, to provide researchers with recombinant protein drug process impurity analysis services, including but not limited to host cell proteins (HCP), host cell DNA (HCD), protein A, and defoaming agents.