Development

Biological assays require detection of the target drug in special biological matrices such as serum, plasma, whole blood, urine, lymph fluids or various tissues.


Typical method development parameters that should be investigated include the determination of specificity / selectivity, the generation of a calibration curve in the appropriate matrix allowing an estimation of the analytical range, and the selection of the appropriate statistical evaluation approach. An appropriate bioanalytical method is required to detect drugs at low levels, as well as linearly over an appropriate range. Matrix and stability effects can lead to inaccurate analysis of the analyte; these effects include, among many others, endogenous materials extracted from the biological matrix that may interfere with the analysis, enzymes in the biological fluid that are capable of metabolizing the analyte, plasma proteins to which the analyte can bind, and concomitant drugs that might interfere in the analysis. All these factors have to be considered when planning an analysis.

VelaLabs has gained significant know-how in performing different assay developments, which have led to a high level of expertise in complex matrices thus enabling successful developments of your assay.