This phase is the most critical and of the greatest importance for the rest of the program. At TPL, we pay most attention to the initial protocol development so to ensure the smooth running of the subsequent GLP phase. Methods will be developed on an automated platform if feasible or, if not possible, manually. Method development will be exclusively science- and data-driven.
Our assay development complies with the most recent guidelines on analytical validation of IHC assays, the outcome of which is a qualitative assessment. Our fit-for-purpose validation is rigorous, and enables us to inform you promptly on the outcome of the method validation progress. You will be immediately informed about the most critical validation parameters in order to rapidly aid you with subsequent steps.
Validation parameters:
- target staining specificity
- tissue preparation (matrix) effects
- test item staining sensitivity (i.e. how low in concentration can we go and still detect a specific staining)
- concentration-staining response curve (linear range, plateau range)
- optimum concentration for staining (the lowest concentration of the plateau range)
- intra-run repeatability
- inter-run repeatability (reproducibility).
The validation results may be assessed qualitatively, semi-quantitatively with a grading or using the H-scoring or may be quantitative using an image analysis system (Slide Scorer HS analysis).