Custom developments

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Drug Biomarker Antibody
Antigen Protein Hormone
Raw material, Ab / Ag
Search or development
Test development Accurate reader
Result communication
Current system integration
Setup of medical software

Solutions for your application in 6 to 14 months

RAW MATERIAL DEVELOPMENT

If biological raw material is not commercially available to target your analyte NG Biotech will assure development and production of specific monoclonal or polyclonal antibodies.

fleche-small 1- Feasibility and process design
fleche-small 2 – Immunization
fleche-small 3 – Screening, Selection & Purification
fleche-small 4 – Mass production

Delay: 3 to 6 months

ASSAY DEVELOPMENT

fleche-small 1 – Product specification definition and theoretical validation
fleche-small 2 – Costs and resources analysis
fleche-small 3 – Biological and non-biological material (component) selection
fleche-small 4 – Validation of results
fleche-small 5 – Proof-of-concept validation
 Delay : 2 months
fleche-small 1 – Sensitivy
fleche-small 2 – Specificity
fleche-small 3 – Cross reactivity
Delay : 1 month
fleche-small 1 – Pilot batch production (500 to 1000 tests)
fleche-small 2 – Internal performance study
fleche-small 3 – Accelerated stability study
Delay : 1 month
fleche-small 1 – Production scale up (1000-2000 tests)
fleche-small 2 – High volume production scale biological and non-biological materials validation
fleche-small 3 – Internal quality control panel set up

Delay : 2 weeks
Delay : External evaluations

OTHER CUSTOMISATION

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Optional

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  • Plastic device design
  • Mold and plastic device injection
Delay : 2 months
ADAPTED TO YOUR NEEDS
  • Whole Blood
  • Saliva
  • Fecal material
  • Swab
  • Colloidal Gold
  • Cellulose particles
  • Magnetic particles
  • Fluorescent beads

ASSAY – READER OPTIMIZATION AND VALIDATION

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 Mobile readers
fleche-small  Bench readers
fleche-small  Custom readers
fleche-small 1 – Dose response curve construction developpement
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2 – Algorithms are integrated to reader software
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3 – Control and validation against a reference method
Delay : 1 to 2 months
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Bar Code System
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RFID