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Bioanalysis at Quotient Sciences - Q&A with Stuart McDougall

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Bioanalytical Services

Delivering rapid bioanalytical data in discovery – preclinical – clinical. Bioanalysis is a critical step in the drug development process.  At Quotient, we are experts in the development, validation, and application of bioanalytical assays.  Our dedicated team of bioanalytical chemists are globally recognized and possess over 40+ years of experience in supporting all stages of drug development, from early preclinical through to First-in-Human, Phase I and onwards to Phase II- III studies.
Bioanalytical expertise:
  • Bioanalytical assay development, validation and application
    • LC-MS/MS
    • ICP-MS/MS
    • GC-MS/MS
  • High resolution mass spec
    • LC-TRAP-MS & LC-TOF-MS
  • Rapid turnaround time of preclinical and clinical samples
    • Even quicker with ‘Priority Analysis’ (72 hr TAT)
  • GLP & GCP accredited laboratories
  • Global compliance (FDA, EMEA, MHRA)
  • Expertise in specialist areas
    • Insulin analogues and polypeptide drugs by LC-MS/MS
    • Elemental analysis by ICP-MS
    • Volatile drugs and biomarkers by GC/MS
  • Metabolite Identification
We can help you develop a clearer understanding of what is happening to your drug molecule as it progresses through the body. Our high-resolution instruments can improve the validity and quantity of the data you require.  With our cutting-edge mass-spectrometry platforms, we can identify and quantify analytes to assess if your drug is metabolized in the body.

State-of-the-art equipment includes:

  • LC-MS/MS
  • LC-HR-MS
  • ICP-MS
  • ICP-MS/MS
  • GC-MS
  • GC-MS/MS

Non-clinical and clinical bioanalysis

Quotient provides comprehensive bioanalytical services within a state-of-the-art facility.  The experienced team of globally recognized experts can quickly develop, validate and implement bioanalytical LC-MS, GC-MS and ICP-MS assays for small and large molecule drugs, biomarkers and elements in compliance with regulatory expectations.  Our team have extensive project experience to support all stages of drug development from early preclinical, first in man (FIM) and through to Phase II and III studies.

We produce bioanalytical LC-MS, GC-MS and ICP-MS assays in compliance with regulatory standards. Three of our eight triple quadrupole instruments are new, ultra-high sensitivity Waters XEVO TQ-XS systems equipped with UPLC. In addition to this, we have a Sciex 6600 triple ToF that allows collection of high-resolution MS data and can be used to quantify an impressive range of molecules from small molecules to proteins.  When used in conjunction with the wide range of extraction technologies available to us we can develop highly selective and sensitive assays.

Study types supported:

  • Preclinical toxicology and DMPK studies
  • Phase I
    • First-in-Human (FIH)
    • Relative bioavailability / pharmacokinetics
    • Drug-Drug-Interaction (DDI)
    • Bioequivalence
    • 14C ADME / mass balance
    • Pharmacodynamics / biomarkers
  • Phase II & III
    • Multi-center global trials
We offer bioanalytical services on both a stand-alone basis and as part of a fully integrated program, with expert Pharmacokinetics (PK) and Toxicokinetic (TK) data analysis and reporting, to accelerate your drug development.

Toxicokinetics & Pharmacokinetics

  • Non-clinical and clinical support
  • PK Parameter Calculations
    • Cmx, Tmax, AUC, etc.
    • Phoenix WinNonlin Software
    • Toxicokinetic reports
    • Interim & final PK reports
    • CDISC format/Full Data Sciences

Sample management

  • Fully integrated chain of custody
    Watson LIMS software
  • 1D and 2D barcode accession
  • Datasets in SEND & SDTM format
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