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Contract assay development

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NBCL has extensive development experience across a broad array of immunoassay technology platforms and our team can rapidly deliver you market-ready assays on any immunoassay platform.

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NBCL can help you with contract research in immunoassay design, assay development, optimization and validation. Our expert staff has over 20-year experience in all aspects of immunoassay development and can provide you with technical know-how and assistance to support the design and manufacturing of your in vitro diagnostic assays.

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NBCL’s contract development activities are available for all stages of your immunoassay development process and across a broad spectrum of technology platforms, from enzyme-linked immunosorbent assays (ELISA) to point-of-care systems, as well as automated immunoassay analysers designed for high-throughput testing in clinical laboratories.

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Please contact NBCL to discuss how our immunoassay development expertise might help you

Assay development process​

  1. Assay design and development

    • Identification and sourcing of critical raw materials (polyclonal antibodies, monoclonal antibodies, preservatives, solid phase, clinical samples, etc.)

    • Component formulation (coating buffers, blocking reagents, assay diluents, calibrators, controls, wash buffers, conjugates, etc.)

  2. Assay optimization and verification for robust and sustainable manufacturing as in vitro diagnostic products

  3. Assay validation

    • Performance, stability and package insert claims

    • Clinical and Laboratory Standards Institute (CLSI) compliant assay validation

  4. Design controlled product development

    • Incoming raw materials and acceptance criteria

    • Process documentation (e.g. batch records, SOPs, work instructions) 

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