Host Cell Proteins (HCPs)

Efficient detection methods

The host cells used for recombinant expression contain hundreds to thousands of host cell proteins (HCPs) that can contaminate biopharmaceutical products. Failure to sufficiently reduce impurities early in drug development can reduce drug efficacy or lead to adverse patient reactions. Regulations require reduction of HCPs to the lowest levels possible.

Our partner Cygnus Technologie offers several superior assay kits for HCP analysis:

Host Cell Protein ELISA Kits

- During process development and process validation to obtain relevant and specific data to direct process improvement and decrease HCP contamination.

- During lot release testing for quality control (subject to thorough validation and qualification by each laboratory).

Mammalian, yeast and bacterial HCP Western Blot Kits

- Western Blot Kits for identifying Host Cell Proteins from a number of mammalian cell lines including CHO, NS/0, SP2/0 and A549 cells.

- Western Blot Kits for identifying P. pastoris and S.cerevisiae Host Cell Proteins.

- Western Blot Kit for identifying E.coli Host Cell Proteins.

Host Cell Protein Antibodies

Use an anti-HCP antibody as the key tool for developing broadly reactive or "generic" assays for detecting HCPs in process development and quality control. Then rely on the experience of Cygnus to help you develop custom, process-specific antibodies later, as needed.

Host Cell DNA Detection & Amplification Kits

Cygnus host cell DNA detection kits utilize PicoGreen® DNA binding dye and include DNA extraction reagents and cell-line specific DNA calibrators. The PCR amplification kits contain DNA extraction reagents, DNA calibrators, and validated specific primers that are compatible with your PCR system.

 

HCP Services

Furthermore, Cygnus Technologies offers HCP coverage analysis services by 2D page, Mass Spectrometry and Antibody Affinity Extraction™ (AAE™):

- Learn more about the Mass Spectrometry and Antibody Affinity Extraction™ (AAE™) method in Cygnus' webinar.

- Contact info@biozol.de for more information, if you wish to make use of the services.