Immunoassay Development & Manufacturing

BioCheck provides a variety of services including:

  • Custom Immunoassay Development
           o ELISA
           o Ultrasensitive Immunoassays using Simoa (single molecule array) Technology
  • Antibody Purification and Conjugation
  • Contract Manufacturing and Assembly


    BioCheck performs custom immunoassay development for the biopharmaceutical industry. With over 45 years of collective product development experience, BioCheck can quickly and economically deliver custom assays for any biomarkers.

    BioCheck has developed assays in the area of:

  • Cardiovascular Disease
  • Tumor Markers
  • Infectious Diseases
  • Reproductive and Fertility
  • Steroids
  • Metabolism
  • Diabetes

    BioCheck's clients trust our expertise and capabilities in immunoassay development, regarding us as an extension of their internal R&D department. BioCheck works closely with clients to bring new IVD products to market.

    The development process includes:

  • Feasibility Studies
  • Optimization
  • Performance Data Generation
  • Clinical Sample Testing for Kit Validation
  • Device Master Record
  • Design Transfer


    BioCheck provides monoclonal and polyclonal antibody purifications including:

  • DEAE column
  • Sephacryl Size Exclusion Column
  • Protein A column
  • Protein G column
  • Antigen Affinity Column


    BioCheck uses proprietary methods to prepare stable antibody-HRP conjugates, and antibody-biotin conjugates which are stable for 5+ years.


    BioCheck offers contract manufacturing under its cGMP and ISO 13485 certified facility. Contract manufacturing and assembly include:

  • Microtiter Plate Coating (3+ year stability and excellent reproducibility)
  • Lyophilization of Kit Components
  • Individual Reagent Manufacturing, Dispensing and Labeling
  • Immunoassay Kit Manufacturing, Assembly and Distribution


    If interested, please contact BioCheck at (650) 573-1968 or email at