Performance Study

With 360-HCP ELISAs you have the possibility to identify the most suitable generic HCP ELISA kit for your specific process. The Starter Set (for CHO, E. coli and HEK293) provides all the necessary components, so that you can quickly and easily choose the most appropriate kit type. 

Alternatively, BioGenes' scientists can perform the evaluation (for 360-HCP ELISAs or HCP ELISA kits from other manufacturers) and, after finalization, they can advice you as to the planning of the next work phases. BioGenes’ performance study includes the following service parts:

Performance Study Part 1

Characterization of HCP-containing samples utilizing BioGenes' 360-HCP ELISA kits optionally incorporating kits from other manufacturers, if desired. Ideally, samples would be based on three downstream process (DSP) samples from different process stages (early, intermediate, late stage) provided by the customer.

Opt. Sample Characterization

  •  Determination of the protein concentration in each of the three DSP samples using the Bradford assay 

HCP Determination by ELISA: 

  • Carrying out the ELISAs with three DSP samples using BioGenes' 360-HCP kits or kits from other manufacturers

1D Western Blots and Immunostaining: 

  • Preparation and analysis of 1D Western Blots using antibodies from BioGenes' 360-HCP kits or kits from other manufacturers to check the HCP distribution in process samples

ELISA Quantification & Accuracy Assessment: 

  • Determination of the HCP content, followed by spike experiments to evaluate the accuracy of the chosen 360-HCP ELISA kit (using additionally a mock sample, if available)

Detailed Reporting: 

  • Receive a comprehensive report detailing the methodologies, findings, and results of Part 1

Performance Study Part 2

This part is based on the results from Part 1 of the performance study. 

To confirm the suitability of the selected generic HCP ELISA kit from Part 1, BioGenes offers the HCP coverage determination by comprehensive 2D analysis of a single process sample:


  • Coverage determination using 2D Western Blot
  • Optional: Coverage determination by Immunoaffinity Chromatography (IAC) followed by 2D DIGE analysis
  • Detailed report


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