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Immunochemistry Services |
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| All of our analytical projects are managed by a central team consisting of a project manager (principle investigator), with support from several analysts and a project coordinator. This team approach assures that all aspects of the project from method development and validation, sample receipt, sample analysis and data reporting are handled in the most efficient way possible. Quality Control checks are performed throughout the project so that the most accurate and complete raw data set is transferred for final review by our Quality Assurance department. Quantitative Ligand Binding Assays Our laboratory develops and validates quantitative ligand binding assays for detection of proprietary macromolecule compounds for preclinical and clinical drug trials. Our laboratory has the expertise to develop quantitative assays from scratch, or from a transferred client-specific assay, with the ultimate goal of validation for GLP use in our laboratory. We can also provide assay optimization of pre-existing or transferred methods prior to validation. Finally, we can validate commercial kit-based assays. Immunoassays for the Detection of Anti-Drug Antibodies (Immunogenicity) The development and validation of qualitative and quasi-quantitative ELISAs for the measurement of anti-drug antibodies has become a particular expertise of our laboratory. Because each project offers its own set of challenges and requirements, the immunochemistry project managers work closely with clients to meet their expectations, while assuring that the final validated assay will be accepted by regulatory agencies. Cell Based Assays for the Detection of Neutralizing Antibodies We work directly with our clients to develop and validate cell based assays for the detection and characterization of neutralizing antibodies. These assays are typically conducted along with the immunogenicity assays described above. Cell based assays are developed under GLP conditions to produce various analytical outputs including cell proliferation, cell death, or an ELISA readout. Biomarker Assays Alta has validated a select group of biomarkers that might be useful in the selection of a lead compound, determining the mechanism of action of a compound, or used as a surrogate endpoint for demonstrating efficacy. The assays are fully validated for use in GLP-compliant study designs. We have also developed and validated proprietary biomarker assays for client-specific needs. Examples of previously validated biomarkers are provided in the following list. However, the list of validated assays changes from time to time, so please contact the laboratory for the latest information. |
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