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Custom Host Cell Protein (HCP) Assays

Please see the newest publication in Bioprocess International  October 2017 (BioGenes as coauthor of Novartis Pharma AG).

BioGenes is an expert in the development of highly sensitive Host Cell Protein (HCP) assays. Leading biopharmaceutical companies such as Novartis, Sandoz, Merckle and Rentschler rely on our HCP assay development expertise to prove drug purity.

We develop multiproduct and specific Host Cell Protein (HCP) assays. As a service, we also assess the feasibility of our generic HCP assay kit for your requirements. Multiproduct Host Cell Protein assays are suitable for sponsors who use a proprietary production cell line for multiple products. The assays are generated against cell line–specific Host Cell Protein populations that are prepared from optimised cultivation and fermentation processes. The advantage of a multiproduct HCP assay is that it can be applied like a generic assay except that it is far more sensitive and specific.

BioGenes’ scientists have developed HCP assays for products derived from various cell lines and origins, including CHO, E. coli, yeast, NS/0, moss, avian, duck and human.

Our services include:

  • Project design and management in close cooperation with the customer
  • Inhouse antibody development and characterisation (2D analysis, ELISA, Western Blot)
  • Development of HCP assays in buffer solution and working matrices
  • Qualification/Pre-Validation of HCP assay according to customer’s requirements and ICH guidelines (ICH Q2B)
  • Production of complete kits or assay components
  • Technology transfer to the customer – SOPs and training of the staff

In addition, BioGenes customises multi-product and generic HCP ELISAs and offers:

  • Performance study for selection of suitable HCP assays
  • Optimisation of generic HCP assays
  • Adaptation of HCP assays to customer’s processes


Please contact us or use our questionnaire for your detailed quotation (download).