The analytical method for measuring your biomarker(s) may not be commercially available and may require specific development, validation, and controls.
The more we know about
- science of your biomarker and indication
- expected interactions and effects of your drug product in the intended population
- whether your data will support drug registration, etc.,
the more we can help, setting up an assay fitting the context-of-use (COU) of the biomarker.
We can develop or transfer a method, optimize, qualify or validate customized assays in multiple application fields: detection and quantification of soluble biomarkers, immunophenotyping, ELISpot, anti-drug antibody detection, pharmacokinetic studies, etc.
Our assay validation process relies on bioanalytical method validation guidelines from FDA, EMA, and ICH and white papers issued from the international bioanalysis community (EBF, European Bioanalysis Forum, GBC, Global Bioanalytical Consortium, AAPS American Association of Pharmaceutical Scientists) during international conferences such as the EBF Open Symposium, the AAPS or WRIB (Workshops on Recent Issues in Bioanalysis) annual meetings.
For PK and ADA, we rely on regulatory guidelines.
For biomarkers, depending on their COU, validation parameters may include:
- Minimum Required Dilution (MRD)
- Lot-to-lot consistency
- Short-term & long-term stability
- Impact of pre-analytical step (sample collection, shipment…)