Discovery Phase Bioanalysis Services
Discovery phase bioanalysis services including rapid screening, non-GLP bioanalysis tailored to support your early stage drug development and lead optimization
Intertek provides three 'standard' modes of LC-MS/MS bioanalytical support for drug discovery based upon your requirements. A dedicated LC-MS/MS discovery project team typically delivers data within 5 days after sample receipt, given one-week of advance notice.
Mode I - Rapid Discovery Screen
- Optimize instrument, run curve and samples directly using a generic method without prior assessment.
Mode II – Lead Optimization (non-GLP early Pharmacokinetic (PK) studies)
- Set up and run an extracted curve (protein ppt. or other extraction methods as needed) and QC spikes to evaluate method performance and range (Day 1)
- Assay samples with freshly prepared curve (n=2 at each concentration) and QC spikes (Day 2)
Mode III – Lead Qualification (bridging and non-GLP toxicokinetic studies)
- Intra-assay precision and accuracy QCs (n=5 at low, mid and high)
- Lower limit of quantitation - LLOQ (n=5)
- Room temperature matrix stability (n=3)
- Room temperature extract stability (re-injection of curve and QC's)