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03-0175-00 SMC™ Immunogenicity Bead Based Assay Development Kit

03-0175-00
1 Kit  
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      Overview

      Replacement Information
      Description
      Catalogue Number03-0175-00
      Trade Name
      • SMC™
      DescriptionSMC™ Immunogenicity Bead Based Assay Development Kit
      OverviewAll biological therapeutics have the potential to induce an immune mediated response ranging from benign to severe adverse effects. These effects can encompass diminished clinical efficacy of the biotherapeutic being administered to hypersensitivity, allergic reaction or even cytokine storms. Consequently, regulatory agencies are looking to understand the implications of immunogenicity and are directing the industry to integrate programs for immunogenicity risk management starting in early phase drug development in clinical and pre-clinical.

      Traditionally ELISAs or Electrochemiluminescence (ECL) have been used to identify the presence of anti-drug antibodies (ADA). Though effective for detection, ELISA methods often fail to adequately measure specific antibody response in the presence of circulating protein therapeutic due to the limitation on sensitivity and problems presented on a plate-based format.

      According to FDA Guidance (2019), ADA assays should be sufficiently sensitive to detect low levels of ADA before the amount of ADA impact the PK, PD, safety or efficacy.

      Single Molecule Counting (SMC™) technology, a fluorescent based immunoassay technique, not only offers a magnitude fold increase in sensitivity over current existing technologies, it also enables the development and optimization of homogenous, species-independent ADA assays.

      Combining our Immunoassay portfolio to study the impact on the immunogenicity of a therapeutic can provide great insight into the mechanism of the response. The SMC™ technology can offer increased sensitivity which may assist in the detection of low affinity antibodies and lead to earlier detection of primary ADA response, overcome matrix effects and may reduce drug tolerance. Our MILLIPLEX® kits can offer insight into the mechanism of the response and also help understand the immune complex mediated responses to the ADA. Related products include the high senstivity T cell panels (HSTCMAG-28SK, MHSTCMAG-70K), the complement panels (HCMP1MAG-19K, HCMP2MAG-19K), and the immunoglobulin isotyping panels (HGAMMAG-301K, HGAMMAG-303E, MGAMMAG-300K, MGAMMAG-300E).
      Background InformationSMC™ technology enables the development of ADA assays by the labelling of the drug with capture & detection reagents, and utilization of buffer reagents to develop and optimize the assays. The technology allows the ability to develop a homogenous species-independent assay format that is simple, easy to design and validate. The reduced number of wash steps aids in the detection of low affinity antibodies and decreases assay time. This assay format is often referred to as a “bridging assay” since the ADA acts as a bridge between the drug labelled capture & detection.
      References
      Product Information
      Components
      • Capture Label
      • Detection Label
      • Buffer 1
      • Buffer 2
      • Buffer 3 (10X)
      • Filter Tube Ultrafree Ultracel-20 membrane
      • 10X Wash Buffer
      • Coated Bead Buffer
      • Uncoated SMC Beads
      • Discovery Standard Diluent
      • Elution Buffer B
      • Buffer D
      • 10X Systems/Wash Buffer w/ Proclin
      Applications
      ApplicationSMC™ technology enables ADA assay development by labelling the drug with capture & detection reagents and utilizing buffer reagents for optimization. It allows you to develop a homogenous species-independent assay format that is simple, easy to design and validate.
      Key Applications
      • Single Molecule Counting (SMC™)
      Application NotesIn developing an immunogenicity assay, optimization is required to fully validate for the immunological system being studied. Considerations such as those listed below can be easily studied with the SMC technology platform:
      • Drug tolerance
      • Cut point/Matrix Tolerance
      • Sensitivity/Dynamic range of the assay
      • Reproducibility
      • Reagents suitable for up to approximately 30 bead-based assays.
      Biological Information
      Physicochemical Information
      Sensitivity
      • Further optimization of different variables can take place to produce the most sensitive assay. These include:
        ◦Drug concentration (capture and detection reagent)
        ◦Assay diluents (to mitigate HAMA or other interfering factors)
        ◦Sample volume
        ◦Number of wash steps
        ◦Incubation time
        ◦Standard / sample diluent
        ◦Determination of minimum required dilution (MRD)
        ◦Evaluation of drug interference / tolerance
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Usage Statement
      • Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.
      Storage and Shipping Information
      Packaging Information
      Material Size1 Kit
      Transport Information
      Supplemental Information
      Specifications

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