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Process Integration. Customization Capability.
The current trend involving the development of biologics, including proteins, peptides and therapeutic antibodies, has resulted in new drug development challenges that require intimate understanding of immunology, assay development, and GLP-compliant product development.
ImQuest Bioscience’s extensive experience with tissue culture and assay development is essential for the development of functional bioassays to define the effects of immunogenicity on the function of the biomolecule. ImQuest is involved in the development of ELISA based technology to provide highly sensitive and robust detection of these molecules in biological
matrices as well as technology to evaluate the immunogenicity of these molecules in animals and humans, ImQuest scientific specialists generate a wide variety of immunoassays for use in support of toxicology and clinical trial programs.
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Technology Transfer of existing ELISA or bioassays |
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Feasibility studies to define optimization parameters |
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Assay development and optimization |
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Assay validation (GLP-compliant) |
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Multiple species ELISA adaptation |
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Sample evaluation and reporting |
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Immunoassay Support of Toxicology and Clinical Trials
Technology Transfer
The initial step in the immunoassay development process involves the technical transfer of the assay methodology so that ImQuest scientists can understand and define all critical steps and reagents used in the clients’ methodology.
Feasibility
The feasibility study allows ImQuest to replicate the clients’ assay, determine robustness and sensitivity, and define required development steps prior to validation.
Development
ImQuest will perfect the existing methodology to define the most appropriate, sensitive and robust assay to be validated for use in support of toxicology or human clinical trials.
Validation
Upon completion of feasibility and development, the assay will be validated according to GLP standards. The parameters assessed include accuracy and precision, selectivity, reproducibility, sensitivity and stability. The detection and quantification limits of the assay,
linearity and dynamic range must be determined in order to define sensitivity. Stability issues to be addressed include freeze/thaw effects and long and short-term stability at a range of temperatures. These requirements are designed to demonstrate the robustness of the assay to provide rigorous, quantitative data within defined limits.
Sample Analysis
ImQuest will receive, store and evaluate samples in a GLP-compliant manner.
Species Adaptation
ImQuest scientists will modify an assay to detect product, and perform immunogenicity and neutralization studies sequentially in 3 species as required for toxicology, and the use of the assay in human clinical trials. |
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Immunotoxicology Services
The quantitation of immune end points and enhanced immune evaluations are important to the eventual development of small molecule drugs, vaccines and biologics for broad or chronic human use. When built into safety assessment programs, these immunotoxicology capabilities can lend unique insight into the effects of expected human target doses and accelerate clinical trials for immunomodulatory substances.
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NK cell assays for innate immunity |
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T-cell proliferation assays for cellular immunity |
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KLH ELISA for humoral immunity |
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Host resistance assay |
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Autoimmunity |
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Functional Immunology Services
ImQuest’s expertise in immunology and assay development permits the rapid evaluation of immune modulation by therapeutics targeted at infectious disease, cancer and inflammatory disease. These functional immune assays measure the effects of therapeutic intervention on cellular, humoral and innate immunity, including measurement of cytokine responses.
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Flow cytometry |
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ELISPOT |
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Intracellular cytokine staining |
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Functional T-cell assays |
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Functional B-cell assays |
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Functional monocyte-macrophage assays |
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Dendritic and reticular endothelial cell assays |
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NK cell response |
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Oxidative burst assays |
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Phagocytosis and apoptosis evaluation |
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Strategic Science. Regulatory Planning.
The quest for clinical products begins with strategic science and ends with effective regulatory planning.
Based on years of research experience in the discovery of new chemical entities and biological products and an intimate understanding of FDA requirements for approval, ImQuest’s strategic planning services will provide preclinical pharmacology, toxicology, and chemical manufacturing guides for therapeutic development.
Acting as consultants and program managers, our staff will use their specialized knowledge and experience to direct well-designed safety and efficacy programs that are fully harmonized with the global development practices critical to the success of a drug.
These services – either collaborative or unbiased third party review of existing plans– is integral for internal strategic planning, and investment estimates. |
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