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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
Antibody 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.
 | 1- Feasibility and process design |
| 2 – Immunization |
| 3 – Screening, Selection & Purification |
| 4 – Mass production |
Delay: 3 to 6 months
Assay Development
Step 1 Feasibility study
1 – Product specification definition and theoretical validation
2 – Costs and resources analysis
3 – Biological and non-biological material (component) selection
4 – Validation of results
5 – Proof-of-concept validation
Delay: 2 months
Step 2 Concept & product optimization
1 – Sensitivity
2 – Specificity
3 – Cross reactivity
Delay: 1 month
Step 3 SCALE UP validation
1 – Pilot batch production (500 to 1000 tests)
2 – Internal performance study
3 – Accelerated stability study
Delay: 1 month
Step 4 Assay Development
1 – Production scale up (1000-2000 tests)
2 – High volume production scale biological and non-biological materials validation
3 – Internal quality control panel set up
Delay: 2 weeks
Delay: External evaluations
Other Customisation
Cassette – Design & Conception
Optional
- Plastic device design
- Mold and plastic device injection
Delay: 2 months
Sample Collection
ADAPTED TO YOUR NEEDS
- Whole Blood
- Saliva
- Fecal material
- Swab
Signal reagent Selection
- Colloidal Gold
- Cellulose particles
- Magnetic particles
- Fluorescent beads
Assay – Reader Optimization and Validation
Assay calibration for your application to:
| Mobile readers |
| Bench readers |
| Custom readers |
Specific Algorithm Integration
| 1 – Dose response curve construction developpement |
| 2 – Algorithms are integrated to reader software |
| 3 – Control and validation against a reference method |
Delay: 1 to 2 months
Assay-Reader Link
| Bar Code System |
| RFID |