HCPs are challenging to detect
A variety of cell lines are used for biotherapeutic production. These include bacteria, yeast, and mammalian cells such as CHO. Each cell line produces a different HCP profile, which can vary according to the biopharmaceutical manufacturing process and the nature of the expressed drug. This diversity makes HCP detection extremely challenging, and since a single assay format to identify the complete spectrum of HCP components is currently unavailable it is often necessary to employ multiple methods.
Reagents and services for HCP monitoring
Commercially-available reagents for HCP monitoring include antibodies raised against individual contaminants, as well as antibodies which have been developed to detect protein fractions derived from a specific cell line. These reagents are often used for 2D Western blot analysis of HCPs, which can deliver superior insight over one-dimensional methods.
Another option available to researchers wishing to perform HCP analysis is to have an HCP antibody custom-synthesised. For example, an HCP fraction from the customer’s own manufacturing process can be separated into high molecular weight (HMW) and low molecular weight (LMW) components by ultra-filtration, and these can subsequently be used as immnuogens.
In addition to HCP antibodies, our product portfolio includes recombinant HCPs, ELISA kits, and kits optimised for HCP detection by Western blotting.