Method Development Strategy
The method development team consists of dedicated scientists with 150+ years of combined experience in the bioanalytical and method development fields. Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:
- Extremely low LLOQ
- Low sample volume
- Large dynamic ranges
- Analysis of multiple metabolites
- Analysis from various matrices (plasma, serum, CSF, blood, urine, etc.)
- Quick method development for high throughput assays using strict criteria
- Successful method transfer or adaptations
Technologies
We are working on methods using new and/or high throughput technologies, such as the Dried Blood Spot analysis (DBS). We are currently performing extensive work on DBS technology and have performed comparison work to determine the correlation between plasma and DBS results during a clinical study.
Our expertise enables us to overcome challenges like potential stability issues and matrix effects. We have performed extensive work on the removal of phospholipids from plasma during solid-phase and liquid-liquid extraction. The presence of the phospholipids is one of the frequent causes of matrix effect observed in bioanalysis.
Metabolites
One area of focus is to develop methods that are free of interference from metabolites. All molecules and potentially unstable metabolites such as glucuronides, sulfates and lactones are tested whenever possible using authentic reference standards. With the reference standard, multiple evaluations, including all stability evaluations, are performed to prove the absence of ex-vivo and in-vitro conversion. Also, we have developed multiple approaches to avoid interference from labile metabolites, especially for the mass spectrometer in-source and/or interface conversion of glucuronide metabolites. Techniques such as the utilisation of adduct ions for analyte monitoring or use of different ionisation modes are employed to avoid such interference.
