Non-Regulatory Bioanalysis

Understand the drug metabolism of your compound by identifying which metabolites are formed during in vitro or in vivo studies.

Discovery Bioanalysis is part of Cyprotex's portfolio of ADME services. Cyprotex delivers consistent, high quality data in line with regulatory guidelines, and can adapt protocols based on specific customer requirements.

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Cyprotex has a wide breadth and depth of experience in Discovery bioanalysis for small molecules and bio-therapeutics including: peptides, oligonucleotides and protacs. The scientific experience, capacity and application of the state-of-the-art bioanalytical equipment provide fast turnarounds that will help to arrive at “go/no-go” decisions faster. Our bioanalysis service is part of both standalone services as well as in vivo PK study packages.

Non-Regulatory Bioanalysis

We can offer non-GLP bioanalytical services with the option qualify methods to support fit-for-purpose analyses.

Reliable and robust bioanalytical methods are critical for quantitative analysis. Developing a bioanalytical method requires an understanding of structural and physicochemical properties of the test compound as well as the matrix environment in which it is being measured in order to optimise the method and identify the most favourable detection chromatographic separation and sample preparation techniques.

Our advanced bioanalytical method development and qualification service is used to demonstrate that a particular bioanalytical method used for quantitative measurement of analytes in a given biological matrix is reliable and reproducible for the intended analytical application. The fundamental parameters assessed include accuracy and precision, linearity and sensitivity, selectivity, recovery and stability.

For routine screening of compounds, we employ a number of generic LC-MS/MS optimisation and analysis procedures which guaranteed high quality optimisation.

Range of Services and Capabilities

• Method development and transfer
• Method qualification
• Non-GLP analysis in support of pre-clinical studies

• Dose-formulation analysis
• Analysis of biomarkers and endogenous compounds
• Support to invitro studies
• New modality Analytical support (eg Protacs, Peptides, Oligonucleotides)

Experience

• Chromatography using different separation modes (including Hilic, Ion pair, Ion exchange and Chiral Chromatography)
• Mass spectrometry including high-resolution MS
• Microsampling analysis
• Analysis of chiral compounds
• Analysis in a wide range of biological matrices like plasma, urine, serum, whole blood, CSF, PBMC and any kind of animal tissues
• Generation of PK Calculations using WinNonlin software

Mass Spectrometry Platforms

• Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
• Liquid chromatography-high resolution mass spectrometry (LC-MS, HRMS)
• Selexion differential ion mobility

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Tissue (typically 50 – 70 mg) is diluted with aqueous solvent at a ratio of 1 g of tissue to 4 mL of water. The tissue is homogenised in a sample homogeniser. The homogenates are either analysed undiluted against matrix matched calibration standards that have been prepared from control tissue homogenised in the same way or diluted 1 to 9 with plasma or blood and then analysed against plasma /blood calibration standards respectively.

We aim to deliver Excel reports format concentration data within 5 working days for liquid matrices and 10 working days for liquid matrices plus tissues. Please note that these times may vary depending on study and method complexity.

Single analytical run. Duplicate standard curve and n=6 QCs at minimum 3 levels. Parameters evaluated:

• Linearity
• Selectivity
• Accuracy and Precision on freshly spiked Quality Controls
• Carryover
• Internal standard reproducibility

Optional

• Stability to support sample processing
• Recovery
• Matrix effects
• Reinjection stability