Host cell proteins (HCPs) are proteins produced or encoded by the host organisms used to produce recombinant therapeutic proteins. Recombinant therapeutic proteins are usually produced by genetically-modified prokaryotic or eukaryotic host cells using cell culture/fermentation technology.
What causes host cell protein?
What is host cell protein analysis?
Host Cell Proteins (HCPs) are a heterogeneous, complex group of proteins that derived from the host cell. Moreover, the regulatory agencies examine each protein drug on a case-by-case basis to determine appropriate maximum acceptable levels of HCPs and patient risk. …
What is host cell protein and DNA?
Dr. Residual host-cell proteins (HCP) and DNA are process impurities that remain in a recombinant drug product following purification. … In contrast, many different types of proteins are expressed by a host cell, and they occur over a wide range of concentrations.
What is host cell line?
These cells express recombinant proteins with post-translational modifications compatible to humans; they do so by secreting the protein of interest into their environment. …
What is HCP in biology?
Host cell proteins (HCPs) are process-related protein impurities that are produced by the host organism during biotherapeutic manufacturing and production.
What is host cell DNA?
Host–cell DNA is an upstream-derived process-related impurity in drug substances derived from a cell culture process, often the result of cell lysis, or rupture resulting from physical exertion (e.g., shear forces, excessive air bubbling, etc.) in a culture vat or cell pelleting or removal during harvest.
How is host cell protein measured?
To date, immunoassay, commonly in the form of sandwich enzyme-linked immunosorbent assay (ELISA) (see Figure 1), remains as the industry gold standard for HCP measurement due to its high sensitivity and high throughput (3, 5).
How are host cell proteins determined?
Methods to Detect Host Cell Proteins in Biopharmaceutical
- Enzyme-linked immunosorbent assay (ELISA) Among the methods of HCPs analysis, anti-HCPs ELISA is considered the gold standard. …
- Two-dimensional gel electrophoresis (2-DE) …
- Mass spectrometry (MS)
19-Oct-2020
What happens when a virus enters a host cell?
During attachment and penetration, the virus attaches itself to a host cell and injects its genetic material into it. During uncoating, replication, and assembly, the viral DNA or RNA incorporates itself into the host cell's genetic material and induces it to replicate the viral genome.