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Non-GLP and discovery bioanalysis

When you need to make pivotal decisions about progressing lead candidates from discovery PK and efficacy studies as part of the Design, Make, Test and Analyse (DMTA) cycle, no-one knows better than us how much speed is of the essence. It’s vital to ensure rapid turnaround of results to measure drug concentrations in the biological samples collected.

At Alderley Analytical, we offer non-GLP and discovery bioanalytical services to support your In-Vivo studies. Our discovery assay approach via UPLC-MS/MS or UPLC-HRMS/MS can quickly analyse samples for compound concentrations and results are provided in as little as 3 working days after receipt of samples, helping you to rapidly discover and progress the best drug candidates.

The discovery bioanalytical process consists of three stages:

  • Generic assay check
  • Sample analysis
  • Data analysis and reporting

Once your lead candidate has been selected in the discovery analytical process, these methods can be qualified to support preliminary toxicology and dose range finding studies. As we have GLP accreditation and can also claim GCP compliance, we can further validate the assay to current FDA/EMA guidelines to support your regulatory pre-clinical safety studies and the later clinical sample studies.

Generic assay check

In discovery bioanalysis, we typically start with a default protein precipitation LC-MS/MS method that is applicable to the vast majority of small molecule compounds, eliminating the need for method development or qualification. The compound will initially be evaluated to ensure our generic methodologies are fit for purpose, or to see if our methodologies need to be adjusted.

Features of the methodology include:

  • Assay range of 1–10,000 ng/mL (modified as required)
  • Sample aliquot volume default of 10 µL of biological matrix

The assay will be designed on our UPLC chromatographic systems with Tandem MS (MS/MS) detection, to achieve appropriate sensitivity even with such small sample aliquots.

Discovery sample analysis

The samples will be stored in our secure monitored storage facility (-20°C or -80°C) until analysis.

The sample run will contain the following:

  • A calibration curve with a minimum of 6 calibration Standard levels
  • Quality Control (QC) samples to monitor assay performance
  • Analysis of formulation concentrations where required

Data analysis and reporting

When the analytical run(s) have been performed and met our acceptance criteria they will be evaluated by one of our trained scientists to ensure the data is of a suitable quality.

The data will then be:

  • Tabulated into the requested format (spreadsheet or word report)
  • PK parameters will be calculated where appropriate
  • Subjected to an internal Quality Control (QC) check

And finally, sent to you in your required format.

Alderley Analytical can also provide your complete In-Vivo PK study. Please get in touch for further details.