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Host Cell Proteins

Host cell proteins (HCPs) are process-related impurities which occur during biopharmaceutical manufacturing. Derived from the host organism used to express a recombinant protein drug, HCPs can affect the efficacy of the biomolecule and may also cause immunogenicity. For biopharmaceutical companies to meet regulatory guidelines and to assure product quality and safety, identification and quantification of HCP contaminants is essential.

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.

Target Antigens ELISA Type Ab Type Human Mouse Monkey Rabbit Others
E. coli Ag - X
Ab IgG X X   X  
Ab IgM X        
CHO Ag - X
Ag - X
Chicken (eggs ovalbumin) Ag - X
Ab IgA   X      
Ab IgG X X   X X (Rt)
Ab IgG1   X      
Ab IgG2a   X      
Ab IgG2b   X      
Ab IgG3   X      
Ab IgE X X     X (Rt)
Ab IgM X X     X (Rt)
Bovine, BSA Ag - X (for measuring residual BSA in vaccines)
Bovine, Lf Ag - X for measuring residual protein in the milk of transgenic animals
Bovine, IgG Ag - X for measuring residual protein in vaccine grown in bovine serum or transgenic animals
Bovine, Tf Ag - X for measuring residual protein in vaccine grown in transgenic animals
Bovine, Albumin Ab IgG X X   X  
Protein A Ag - X
Protein G Ag - b
Human Albumin Ag - X for measuring HSA in vaccines