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ELISA Development Services

GenWay’s experience in development of proteins and antibodies allows for rapid, high quality development and validation of ELISA assays. We routinely develop and utilize assays for specific analysis needs. Based upon our capability and core competency in proteins and antibodies, we can providing first-in-class assay development and standardization for our clients.

Development

  1. Collect and test matching antibodies, reagents, and control samples
  2. Optimize assay conditions for kit components and samples
  3. Determine incubation times and temperatures
  4. Establish acceptance criteria
  5. Perform sensitivity and precision analysis
  6. Specify upper and lower limits of detection and quantitation
  7. Control lot to lot consistency

Validation

  1. Draft validation protocol and document sample requirements
  2. Perform validation testing and report validation results
  3. Comply with ISO/GMP/CLIA requirements as defined by customer
  4. Comply with customer supplier qualification requirements

Quality Management System

  1. Quality Policy Manual - Quality System Procedures, Control of Documents, Control of Quality Records
  2. Product Realization – Planning, determination of requirements
  3. Production – Control, validation of processes, traceability, product preservation

Contact us and receive a quote within 24 hours
  • Email: sales@genwaybio.com
  • Phone: 858.458.0866
  • Clinical / CLIA Testing Services GenWay’s Clinical Laboratory Services work with your clinical, scientific, and egulatory personnel to define study objectives and specifications. Based on your needs, we provide a project budget and timeline including milestones and deliverables. GenWay has the assay development knowledge to develop, optimize and validate ELISA kits for use in clinical or pre-clinical trials Methodologies – Sandwich, direct/reverse capture, competitive ELISA. Targets – Infectious disease, biomarkers, biochemicals, hormones, serological assays, auto-immunity Samples – Serum, plasma, tissues, biological fluids, live cells, cell culture samples or lysates Platforms – colorimetric, chemiluminescent, fluorescent, rapid/one-step, lateral flow, multiplexing Contact us to learn how we can support your ELISA development needs or fill out the custom quotation form above.