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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 |
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.
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1- Feasibility and process design |
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2 – Immunization |
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3 – Screening, Selection & Purification |
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4 – Mass production |
Delay: 3 to 6 months
ASSAY DEVELOPMENT
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1 – Product specification definition and theoretical validation |
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2 – Costs and resources analysis |
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3 – Biological and non-biological material (component) selection |
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4 – Validation of results |
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5 – Proof-of-concept validation |
| Delay : 2 months | |
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1 – Sensitivy |
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2 – Specificity |
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3 – Cross reactivity |
| Delay : 1 month | |
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1 – Pilot batch production (500 to 1000 tests) |
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2 – Internal performance study |
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3 – Accelerated stability study |
| Delay : 1 month | |
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1 – Production scale up (1000-2000 tests) |
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2 – High volume production scale biological and non-biological materials validation |
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3 – Internal quality control panel set up |
| Delay : 2 weeks Delay : External evaluations |
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OTHER CUSTOMISATION
Optional
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| 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
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Bench readers |
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Custom readers |
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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
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Delay : 1 to 2 months
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Bar Code System |
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RFID
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