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Specialist laboratory services

Alderley Analytical works with biotech, pharma and CROs around the world, to offer a discovery and regulatory bioanalytical service. We develop and validate assays for small molecules, peptides, large molecules and biomarkers to support analysis in all stages of the drug development process, from discovery through regulatory pre-clinical and clinical phases. As a GLP and GCP accredited lab, our laboratory services include the validation of bioanalytical methods to current FDA/EMA guidelines.

DISCOVERY BIOANALYSIS

Quantify a new molecule in a biological matrix to determine the pharmacokinetics or In-Vivo exposure.

PRE-CLINICAL BIOANALYSIS

GLP compliant pre-clinical bioanalysis and toxicokinetic interpretation to support your In-Vivo drug safety packages.

CLINICAL
BIOANALYSIS

Full GCP accredited bioanalytical support for clinical projects including phase I-IV clinical studies

The process which underpins our laboratory services includes the following stages:

 

  • Method development
    • Defines the method, provides sound scientific evidence for the method design and checks its suitability for its intended purpose
  • Method validation
    • Ensures that the method is linear, reliable and reproducible and is sufficiently sensitive, stable, selective, accurate and precise
  • Stability testing
    • Robust methods to ensure the molecule or compound retains its qualities over its lifespan and in different environments
  • Sample analysis
    • A matrix-based standard curve is generated for each analytical batch for each analyte and is used for calculating the concentration of analyte in the unknown samples analysed with that run
  • Reporting
    • Your formal study report can be presented in a template you provide, or you can choose one of our in-house templates

Partnership services

We have a network of partnerships with other providers, who support us as necessary where the demands of a project require a wider collaboration. We regularly work with service providers in the following areas.