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Discovery Bioanalysis

We provide a rapid fit-for-purpose bioanalytical service for in vitro and in vivo discovery studies.

We undertake quantitative LC-MS/MS analysis of drugs, metabolites and biomarkers in a range of matrices, including plasma, blood, dried blood spots (DBS), urine, bile, tissue homogenate and in vitro samples. We can provide bioanalytical data and scientific guidance to support discovery studies including PK, PKPD and exploratory toxicology.

We offer a tiered approach to bioanalysis, ranging from simple, largely generic methodologies to pre-qualified assays incorporating bespoke method development.  As a minimum, our assays involve compound optimisation on the relevant mass spectrometry system, internal standard response checks, carry-over assessment, calibration curve acceptance criteria and evaluation of linearity and regression models.

Beyond the most simple tier, additional quality criteria are introduced either as a component of the standard sample assay batch or as part of a pre-qualification process.  These criteria include QC samples with fit-for-purpose acceptance criteria, matrix effects, recovery and vehicle effect experiments, accuracy and precision evaluations and assessments of dilution integrity.

Using state-of-the-art instrumentation, including:

  • AB SCIEX API 5000 mass spectrometers
  • AB SCIEX API 4000 mass spectrometers
  • Agilent 1290 high-resolution LC systems
  • Hamilton Microlab Star robots
We use our experience and expertise to deliver fit-for-purpose, high-sensitivity bioanalytical data in a diverse range of species and matrices with an average 3-4 working days cycle time.

  Tier 1 Tier 2 Tier 3
Compound Optimisation Yes Yes Yes
Pre-qualification None Sensitivity, retention, peak-shape, and extraction from matrix reviewed for suitability at a single concentration prior to commencing assay Single qualification batch containing: full calibration curve, QC samples (n=6 at low, mid, high and LLOQ), dilution QC samples (n=6 at a single concentration), matrix effect and recovery testing (at low and high QC levels) and selectivity. Relevant Tier 3 acceptance criteria apply
Analytical Standard (AS) & Internal Standard (IS) AS: Supplied as solid (=1mg) or liquid (=10µl) IS: Generic AS: Supplied as solid (=1mg) or liquid (=10µl) IS: Generic or structural analogue AS: Supplied as solid (=5mg) preferred IS: Structural analogue or stable isotope label if possible
Methodology Protein precipitation Generic reversephase gradient with on-line clean-up step Non-primary matrix diluted in plasma Extraction optimised: Liquid-liquid if possible Generic reverse-phase gradient with on-line clean-up step Non-primary matrix diluted in plasma with =1 matrix-matched QC Extraction optimised: Liquid-liquid or solid phase Optimised chromatography if required Each non-primary matrix assayed against matrix-matched calibration curve and QCs where possible
Calibration Curves Typical 0.5-1000 ng/ml (n=10) =75% within 30% nominal Typical 0.5-1000 ng/ml (n=10) =75% within 20% nominal Assay specific range (n=10) =75% within 20% nominal
Quality Control Samples None =2 at 3 levels (low, med, high) Dilution QC (n=3) =66% within 20% nominal n=2 at 3 levels (low, med, high) Dilution QC (n=3) =66% within 20% nominal with =50% at each level
Selectivity None <33% LLOQ detectable in blank from 3 matrix lots <20% LLOQ detectable in blanks and =66% within 20% nominal for low QCs from 6 matrix lots
Carry-Over <33% LLOQ <33% LLOQ <20% LLOQ
Stability None None Freeze/thaw, room temp and sample extract stability on request
Recovery/Suppression None Recovery and matrix checks at 1 level Vehicle effect check via dilution =66% diluted samples agree within 20% of neat assay Recovery and matrix checks at 2 levels in pre-qualification, 1 level within assay batch Vehicle effect check via dilution =66% diluted samples agree within 20% of neat assay
Reporting Excel data summary Excel data summary Report including methodology

For further details on our discovery bioanalysis services and to discuss your specific requirements please contact us on +44 (0) 1904 686060 or email  info@yorkbio.com
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