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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.

Antibodies

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Proteins

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Assay Kits

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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.

 

Vaccine

Target Antigens

ELISA Type

Ab Type

Human

Mouse

Monkey

Rabbit

Others

Host Cell Proteins (HCPs)

E. coli

Ag

 

-

800-130-ECP; E Coli proteins (5 strains) host cell proteins (HCPs) ELISA kit

Ab

IgG

500-110-ECP

500-100-ECP

 

500-120-ECP

 

Ab

IgM

500-115-ECP

 

 

 

 

CHO

Ag

-

800-140-CHO, Chinese Hamster Ovary Cell (CHO) host cell Proteins (HCPs) ELISA kit

Ag

-

6020, Chicken IgG ELISA for vaccine components grown in chick embryo

Chicken (eggs ovalbumin)

 

 

Ag

-

6050, Chicken Egg Ovalbumin (Gal d 2) ELISA Kit in vaccine components

Ab

IgA

 

600-150-OGA

 

 

 

Ab

IgG

670-140-OVG

600-105-OGG

 

620-100-OGG

610-100-OGG (Rt)

Ab

IgG1

 

600-110-OG1

 

 

 

Ab

IgG2a

 

600-120-O2A

 

 

 

Ab

IgG2b

 

600-130-O2B

 

 

 

Ab

IgG3

 

600-140-OG3

 

 

 

Ab

IgE

670-150-OVE

600-165-OGE

 

 

610-110-OGE (Rt)

Ab

IgM

670-145-OVM

600-170-OGM

 

 

610-120-OGM (Rt)

Bovine, BSA

Ag

-

8100, Bovine Albumin (BSA) ELISA Kit (for measuring residual BSA in vaccines)

Bovine, Lf

Ag

-

8090, Bovine Lactoferrin ELISA Kit for measuring residual protein in the milk of transgenic animals

Bovine, IgG

Ag

-

8010, Bovine IgG ELISA kit for measuring residual protein in vaccine grown in bovine serum or transgenic animals

Bovine, Tf

Ag

-

8070, Bovine Transferrin ELISA kit for measuring residual protein in vaccine grown in transgenic animals

Bovine, Albumin

Ab

IgG

710-140-BSM

710-130-BSM

 

710-110-BSR

 

Protein A

Ag

-

800-110-PRA, Protein-A ELISA Kit, 96 tests, Quantitative

Protein G

Ag

-

800-120-PRG, Protein-G ELISA Kit, 96 tests, Quantitative

Human Albumin

Ag

-

1190, Human Serum Albumin (HSA) ELISA Kit for measuring HSA in vaccines

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