SDS-PAGE Detection of Host Cell Protein (HCP) Residues

HCP (host cell protein) refers to host cell protein or residual host protein, which are low-level protein impurities derived from the host organism in drug products during biopharmaceutical processes. During the expression of recombinant protein drugs, the host cell system can express many endogenous proteins. These host cell proteins in recombinant biotherapeutics can significantly affect drug efficacy and trigger immune responses in the body, presenting potential risks. Therefore, strict quality control over such drugs is necessary.

Host protein residual detection refers to the detection of whether recombinant protein drugs contain other host impurity proteins. SDS-PAGE gel electrophoresis visualizes proteins by separating them based on their molecular weight. Proteins of different relative molecular weights can be separated into different protein bands by electrophoresis. By observing the protein bands after electrophoresis, one can quickly determine the purity of a protein sample. If only one band with the same molecular weight as the protein drug appears after SDS-PAGE electrophoresis, it indicates that the protein drug does not contain other host proteins. Conversely, if other bands appear, it indicates the presence of other host proteins. SDS-PAGE can not only assess the purity of recombinant protein drugs but also detect the results of HCP purification.

Baitaipike Biotechnology uses the Bio-Rad Mini-PROTEAN® Tetra gel system and Thermo's latest Obitrap Fusion Lumos mass spectrometer, combined with nanoLC-MS/MS nanoliter chromatography, to provide services based on SDS-PAGE and mass spectrometry forhost cell protein residual (HCP)analysisservice packages. You only need to inform us of your requirements and send samples, and we will handle all subsequent project tasks. Baitaipike Biotechnology also offers customized analysis services to meet different experimental needs, welcome to consult for free.

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