Contract development (CDMO)
You define the analyte, sample matrix and intended use. We take the assay from antibody sourcing to a registered, manufactured product under a single quality management system.
Development begins with feasibility. We source and pair antibodies, screen the sample matrix and build a proof-of-principle prototype in the target format. The feasibility report is a stand-alone deliverable, so performance data is available before further commitment.
The assay then proceeds through optimization and verification under ISO 13485 design control. Sensitivity, specificity, precision, interference and stability studies are documented in a design history file that is available for audit at any stage.
Design transfer into our WHO-GMP facility in Hyderabad comprises the device master record, line qualification, process validation and pilot lots, followed by routine manufacture with full lot release documentation.
Formats: LFIA · ELISA · CLIA · Deliverable as registered kit or design-transfer package
You bring
- Analyte and intended use
- Sample matrix and use setting
- Performance targets: sensitivity, specificity
- Expected annual volumes
We deliver
- Feasibility report with prototype data
- Optimized assay design under ISO 13485 design control
- Verification data package and stability program
- Design transfer into WHO-GMP manufacture
- Registered kit, or a design-transfer package if you manufacture elsewhere
Discuss a development requirement
Analyte, format and expected volumes are sufficient for an initial assessment.