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Laboratory Services –UK |
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Veeda CR’s on-site laboratory was established in 1996 as a purpose built facility to serve the clinical trials industry. The laboratories are GLP accredited and offer a truly world class facility providing a comprehensive range of laboratory services, from basic laboratory safety analyses to more complex testing regimes requiring specialist techniques. The UK laboratory has a proven track record for ligand binding pharmacokinetic analysis, Immunogenicity (Antibody monitoring), and the analysis of Biomarkers. |
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Services Offered |
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Routine Safety Assessment i.e. Clinical Biochemistry, hematology |
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Method development |
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Establishment of immunoassays in biological matrices from different species |
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Validation of immunoassay techniques to FDA guidelines in accordance with GLP/GCP regulations |
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Bioanalysis for parent drug and metabolite concentrations in samples generated from preclinical and clinical studies for Toxicokinetic and Pharmacokinetic assessment |
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Measurement of Biomarkers for Research, Drug Development, Pharmacodynamics and Safety assessment |
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Monitoring of antibody response (immunogenicity) |
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| Techniques Currently Offered |
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Veeda CR has a range of state-of-the-art, fully automated analysers, providing rapid, precise and, accurate results. |
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Enzyme based immunoassays i.e. ELISA and EIA |
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Chemiluminescent based Immunoassays (CLIA) |
| Fluorescent based immunoassays i.e. FIA, FPIA and DELFIA |
| Radioactive based immunoassays i.e. RIA, IRMA and RIPA |
| Multiplexed Assays, |
| Flow Cytometry, Cell Based Assays |
| Hybridization Assays, |
| Laser Nephelometry, Turbidometric Assays, Coagulation Assays, |
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Routine Laboratory Safety |
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(Under review, currently serviced by Partner Diagnostic Lab.) |
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Veeda CR has a range of state-of-the-art, fully automated analysers, providing rapid and, accurate results.
Unique laboratory reference ranges are established on site and this together with trial specific programming of the Laboratories’ LIMS data handling system, ensures a flexible approach, tailored to individual client requirements. |
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Chemistry |
| An extensive range of clinical biochemistry analytes are measured, including industry standards such as: |
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Electrolytes
Liver enzymes
Cardiac markers
Glucose
Lipids
Proteins |
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| Haematology |
| Automated analysis of haematological status, including: |
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Red and white cell count
White cell differentials
Platelets
ESR & reticulocytes |
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| Coagulation |
Usual parameters such as PT, APTT, TT, INR and fibrinogen alongside clotting factor assays such as FXa and F11a.
SB Platelet aggregation more text please |
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| Drugs of abuse |
| A variety of methodologies are available to suit client requirements, specific drug class testing and broad spectrum thin layer chromatography is available. |
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| Virology |
| State-of-the-art automated analysis for hepatitis and HIV. |
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| Urinalysis |
| Biochemical analysis of urine for electrolytes and creatinine, etc. Automated urinalysis dipstick testing for ketones, urobilinogen, glucose, protein, etc. |
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| Endocrinology/Immunology |
Routine endocrine testing for beta-HCG, reproductive and thyroid hormones, insulin and specialised bone markers, cytokines, growth factors & biogenic amines.
All assays are determined by the best-matched methods for clients’ needs, taking into account sensitivity and specificity |
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Bioanalytical Services for: Biomarkers, Large molecule PK and Immunogenicity |
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Veeda CR has a proven track record for specialist pharmacodynamic and pharmacokinetic analysis. The provision of Fluorescence Activated Cell Sorting (FACS), and immunoassay techniques allows a flexible approach with an extensive range of assays available. The availability of tissue culture facilities adds cell stimulation and biological marker studies to the extensive repertoire of techniques. |
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| Veeda CR’s in-house assay development team enables the production of client defined ELISAs for PK, PD and antibody analysis to GLP standards. |
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| Facilities and Personnel |
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The VEEDA CR Immunochemistry group has more than 50 years combined experience in performing analytical techniques to support preclinical and clinical services. The immunochemistry group has an excellent reputation in the industry for their technical abilities, problem solving, quality of work and on-time reporting.
The Laboratory Services facility is equipped with state of the art equipment.
Supported by state of the art instrumentation the immunochemistry group has developed and validated a wide array of analytical methods for a variety of biological matrices including plasma, urine and tissues. |
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| Services Offered |
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Method development |
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Establishment of immunoassays in biological matrices from different animal species |
|
Validation of immunoassay techniques to FDA guidelines in accordance with GLP regulations |
|
Bioanalysis for parent drug and metabolite concentrations in samples generated from preclinical and clinical studies for Toxicokinetic and Pharmacokinetic assessment |
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Measurement of Biomarkers for Research, Drug Development, Pharmacodynamics and Safety assessment |
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Monitoring of antibody response (immunogenicity) |
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| Instrumentation |
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| In addition to instruments used for routine clinical pathology safety measurements, Veeda CR has a comprehensive list of state of the art instrumentation:- |
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Molecular Devices SpectraMax M5
Multi-mode microplate reader for UV/visible, fluorescence, time resolved fluorescence (DELFIA), Fluorescence Polarisation and glow chemiluminescence. |
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Grifols Triturus
Robotic analyser for fully automating 96-well microtitre plate assays |
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Luminex 100
Flow cytometry bead-based analyser for multiplex assays i.e. producing analyte profiles |
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DPC Immulite
Automated chemiluminescent analyser with >100 off the shelf diagnostic type assays available – re-optimisation available for different study requirements |
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IL ACL Futura
Analyser for the measurement any part of the Coagulation system |
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Roche Cobas Mira Plus analyser |
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| Techniques Currently Offered |
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Enzyme based immunoassays i.e. ELISA and EIA
Chemiluminescent based Immunoassays (CLIA)
Fluorescent based immunoassays i.e. FIA, FPIA and DELFIA
Radioactive based immunoassays i.e. RIA, IRMA and RIPA
Multiplexed Assays
Laser Nephelometry
Turbidometric Assays
Coagulation Testing
Hybridization Assays |
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| Flow Cytometry |
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| Veeda CR’s 4-colour laser analyser allows sophisticated multiple marker analysis of individual cell subsets. The Laboratories also have experience of FACS use in complex pharmacodynamic protocols, involving in-vitro and in-vivo cell stimulation. |
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| Cell Based Assays |
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Tissue culture facilities enable investigation of cell subsets under in-vivo and in-vitro stimulated conditions, for example evoking and measuring cytokine release.
Cell separation techniques are available to produce specific enzymes required by clients for pharmacodynamic measurements. |
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| Method Development |
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| Method development is carried out in order to minimise time and cost to our sponsors. This is achieved through regular communication with the customers throughout the method development process. Methods are usually either developed from first principles or from preliminary methods provided by the sponsor. The aim of the method development/optimisation process is to ensure that the method will be suitable for formal validation to ensure that the method will meet the latest regulatory requirements. |
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| Method Validation |
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| The analytical methods are validated in accordance with the relevant Good Laboratory Practice regulations and current regulatory opinion. |
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| For a PK assay a Full Method normally includes the following parameters: |
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Precision and accuracy |
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LLOQ |
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Specificity and Selectivity |
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Matrix Effects |
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Parallelism |
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Dilution linearity and Prozone |
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Stability |
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Recovery (if applicable) |
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| NB For immunogenicity and biomarker assays the validation parameters may differ depending on the exact requirements of the clinical/preclinical study. |
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| Quality and Reporting |
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| Analysis and validations are performed in accordance with Veeda CR standard operating procedures, which are based on the latest regulatory guidance documents. The systems and processes are designed to be acceptable to regulatory authorities worldwide. Our staff has a track-record of on-time reporting. |
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