ResourceLife Sciences
Bridging Immunogenicity Assays - Guidelines for Assay Development
Bridging Immunogenicity Assays - Guidelines for Assay Development
8 May 2016Immunogenicity assessment is important in the development of biotherapeutics, such as proteins or antibodies or conjugated peptides or oligonucleotides, that induce an immune response in the body, leading to the development of anti-drug antibodies (ADAs) which can potentially threaten patient safety. Assessment of ADAs as well as neutralizing antibodies (NAbs), which may inhibit the biologic activity of the drug, form an important part of immunogenicity testing. Immunogenicity assays can be challenging due to interferences originating from the sample matrix, drug interference or target interference. This guide presents the development of bridging immunogenicity assays utilizing the Meso Scale Discovery (MSD) Assay Development Pack and MSD technology.
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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.OligonucleotidesOligonucleotides are small nucleic acid polymers, usually less than 20 bases in length. Oligonucleotides can be made via enzymatic cleavage or more commonly by chemical synthesis with polymerases. Their use includes FISH, southern blots, microarrays and as primers in PCR. High fidelity synthesis kits and detection systems are available for easy production and detection, respectively.Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Protein PurificationProtein purification is a vital step in drug discovery, therapeutics, biotech and life science research. The purification process typically involves subcellular or membrane protein extraction with cell lysis kits, separation of proteins from cell debris by filtration or spin columns, and the isolation of proteins of interest from other proteins and impurities with affinity purification (including fusion protein tags and antibody binding proteins A, G and L), immunoprecipitation or chromatographic methods, such as ion exchange, size exclusion and immobilized metal affinity chromatography. All purification methods come in multiple formats for your laboratory needs, including agarose or magnetic beads, resins, columns and filter plates. Find the best protein purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.PeptidesPeptides are short chains of amino acids that play key roles in biological processes, including signaling, immune responses, and enzyme regulation. Peptide research is critical in drug discovery, diagnostics, and vaccine development. Browse our peer-reviewed product directory to find the best peptides and peptide-related products, compare options, check reviews, and get pricing directly from manufacturers.Antibody Drug ConjugatesAssay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.Therapeutic AntibodiesTherapeutic antibodies are antibodies engineered for use in treating diseases. They can be designed to target specific antigens, blocking harmful interactions or modulating immune responses. Therapeutic antibodies are critical in treating conditions like cancer, autoimmune disorders, and infectious diseases. Explore the best therapeutic antibody products in our peer-reviewed product directory; compare options, check reviews, and get pricing directly from manufacturers.Matrix Effects