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BIOANALYSIS, IN-VITRO ADME AND METABOLISM

We are Europe’s leading independent bioanalytical CRO and offer complete bioanalytical support for your entire development process from discovery through to post marketing trials

We provide a full method development or transfer service including method validation, with study plans designed to satisfy the latest regulatory guidelines.

  • We have the instrumentation and capacity to comfortably accommodate your largescale sample analysis studies
  • We routinely support fast turnaround (e.g. first into man) studies
  • We support both preclinical and clinical development and dedicate a percentage of our schedule specifically to carrying out smaller studies, and we recognise the importance of all of our clients
  • We operate a one study per instrument scheduling policy for LC-MS/MS systems, to optimise instrument performance and method reliability

Our services

  • Experienced, proactive and responsive scientists
  • A dedicated SD who is in control of all stages of the process
  • All scientists within their teams qualified to at least degree level
  • Flexible scheduling to meet your timelines
  • High ratio of QA to operational staff, enabling fast reporting of audited data
  • High-quality bioanalytical data and scientific guidance

     

     

  • Immunoassay

          - PK/PD Assays

          - Immunogenicity Assessment

          - Biomarkers

  • Mass Spectrometry

          - PK/PD Assays

          - Small molecule, Protein and Peptide Analysis

          - Biomarkers

 

Our range of state-of-the-art instrumentation includes:

  • MDS SciexTM API 4000 and 5000 LC-MS/MS
  • Waters XevoTM TQ-S LC-MS/MS
  • Waters Acquity UPLC®
  • Shimadzu Nexera UHPLC
  • Spark-Holland SymbiosisTM Pharma
  • Cohesive TurboFlowTM HTLC systems
  • Hamilton MicroLab Star Liquid Handling Workstation

Whilst we have a list of validated methods, we recognise that you might require your methods tailored to specific concentrations in specific matrices for specific indications. Contact us to hear more about how we can provide tailored methods validated on a zero or low cost basis.

Examples of our experience

Bioanalytical experience

  • More than 20 years and 3,500 bioanalytical studies conducted on small and large molecules
  • Developing, validating and implementing sub pg/mL assays
  • Experience with immunogenicity towards viral vectors
  • Experience with LPL deficiency testing, coagulation factors, FIX activity, FIX protein, FIX Inhibitors
  • Experience with multiple sample types including blood, urine, faeces, tissue and CSF

In-Vitro ADME and Metabolism

  • Bioanalytical and ADME support for complex analytes and atypical drug modalities including In Vitro ADME screening
  • Full metabolite characterisation service from early discovery in vitro experiments to late development radiolabelled studies
  • Discovery Bioanalysis - Rapid fit-for-purpose service for in vitro and in vivo discovery studies

 

Bioanalysis

We provide data and knowledge to clarify key biotransformation issues 

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