LFA Development: Optimisation
The Optimisation stage refines the feasibility prototype into a robust, scalable assay design with clearly defined processes and specifications, ensuring consistent performance under expected manufacturing and use conditions while generating data to support downstream verification, validation, and scale up.
Activities include optimisation of reagents, conjugates, membranes, and buffers, alongside characterisation of assay kinetics and assessment of manufacturing relevant parameters such as coating, drying and assembly to support reproducible performance at scale.
Indicative performance characterisation studies define analytical sensitivity, specificity, precision, robustness, and stability, while critical process parameters and quality attributes are identified and documented. ISO 13485 design control principles are applied throughout, supporting risk management, traceable design specifications, evidence based decision making.
The Optimisation phase results in a defined assay design with established processes, specifications, and performance data to support formal Performance Verification, validation, and transfer to manufacture.
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To discuss how our Optimisation services can be tailored to your Lateral Flow Assay development programme, please contact our team below.
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Key Deliverables
Assay Parameter Finalisation
Overview
Finalisation of process parameters such as material preparation and drying.
Process & Material Robustness
Assessment of process scalability and material robustness, including lot-to-lot variation to support reliable manufacturing.
Defined Specifications
Finalisation of assay specifications encompassing preparation, assembly, and quality control processes, providing a clear framework for manufacturing and verification.
Performance Characterisation
Agreed indicative evaluation of assay performance e.g. analytical sensitivity, specificity, precision, reproducibility, and interference.
Pilot Batch & Production Readiness
Production of pilot batches under manufacturing-relevant conditions, including process verification and staff training, to confirm scalability and reproducibility
Stability Assessment
Indicative stability studies on the finalised assay to support early shelf-life insights and define acceptable storage and handling conditions.
Design Freeze & Documentation
Completion of design freeze with formal approval of assay design, manufacturing documentation, QC protocols, and specifications to support formal verification and validation.
Design Review
Review and confirmation that optimisation objectives, assay performance, and specifications have been achieved.