Discovery Bioanalysis

We deliver high-quality data faster, without sacrificing its usability or quality. 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 five 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)  
  
  

Total Quality Assurance for Bioanalysis Discovery Programs

With the integration of advanced analytical technologies and a heritage supporting bio/pharmaceutical product development, our lab experts provide Total Quality Assurance (TQA) to help you ensure data accuracy and reliability. Intertek's innovative and global pharmaceutical services bring quality, safety, and sustainability to life.