CUSTOM 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

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

1 – Sensitivity
2 – Specificity
3 – Cross reactivity

Delay: 1 month

1 – Pilot batch production (500 to 1000 tests)
2 – Internal performance study
3 – Accelerated stability study

Delay: 1 month

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

ADAPTED TO YOUR NEEDS

• Whole Blood
• Saliva
• Fecal material
• Swab

• Colloidal Gold
• Cellulose particles
• Magnetic particles
• Fluorescent beads

	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