Novel Biomarker-Based Assays

NBCL can assist you with the development and commercialization of your novel biomarker-based assays. Our team has deep knowledge of, and experience with immunoassay technologies, and we will deliver market-ready biomarker assays according to customer specifications.  In addition, with our large network within the in vitro diagnostics (IVD) industry, NBCL is ready to assist our customers in bringing novel diagnostic products to market quickly and cost-effectively. Product marketing can be provided through our distributor network, and we can connect you with larger OEM partners for commercial manufacturing and sale of your products.
 
In order to determine the quickest way to market, NBCL will assess your product requirements based on its development stage. From there, our R&D project leaders will prepare a clear strategy to complete product development, then transfer the product to manufacturing.  NBCL will work closely with your team throughout this process in order to establish the most efficient path to commercialization.  Small scale manufacturing of assays (e.g. for clinical trials and early market entry) can be provided by NBCL as well.
 

NBCL is always looking for new opportunities to partner with companies and research institutes to bring new and innovative diagnostic products to the market.


Contract Research, Assay Design and Development

In addition to novel biomarker-based assay development, NBCL can provide you with contract research in immunoassay design, development, optimization and validation. Our expert staff has over 20 years experience in all aspects of immunoassay development and can provide technical know-how and assistance to support the design and manufacturing of your in vitro diagnostic assays.
NBCL’s contract research 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 analyzers designed for high-throughput testing in clinical laboratories.
  1. Assay design and development
  • Identification and sourcing of critical raw materials (e.g. polyclonal and monoclonal antibodies, preservatives, solid phase, clinical samples, etc.)
  • Component formulation (e.g. coating buffers, blocking reagents, assay diluents, calibrators, controls and standards, wash buffers, conjugates, etc.)
  1. Assay optimization and verification for robust and sustainable manufacturing as in vitro diagnostic products
  2. Assay validation
  • Performance, stability and package insert claims
  • Clinical and Laboratory Standards Institute (CLSI) compliant assay validation  
  1. Design controlled product development
  • Incoming raw materials and acceptance criteria
  • Process documentation (e.g. batch records, SOPs, work instructions)
  1. ISO 9001 and ISO 13485 certifications pending

 
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