How can we help you?
Assay Development
With extensive experience in developing assays on multiple platforms – ELISA, ECL, fluorescence, PCR and cell-based bioassay – I can help you choose the right format for your assays, compose a Method Development Plan, source critical reagents or cell lines and optimize all parameters of the assay. The assay will be designed to provide adequate sensitivity and specificity, with attention to any potential interferences. I can review the Method Validation Plan, have oversight of a qualification or validation and review the Validation Report.
Regulatory Compliance
In the Drug Discovery stage, assays may be fit for purpose; with quality control appropriate for the particular use of the data. Assays supporting GLP studies and clinical trials typically must be validated according to FDA and ICH Guidelines. I can help you navigate these requirements, including audit of your lab or your CRO partner to assure you that your assay data will be acceptable to regulatory agencies.
Data Analysis
The heart of an ADA assay is an appropriate cut point to distinguish positive from negative results. I have extensive experience in calculating cut points using data from drug-naive subject samples. For PK assays, it is important to select the appropriate regression algorithm, determine Limits of Quantitation, Selectivity, Stability and Linearity of Dilution. Cell-based methods to detect neutralizing antibodies (NAb) can be especially tricky to implement. I have managed the development of dozens of such assays.