The Immunology Department is a member of the Discovery Center at MPI Research. The rapid growth and focus on the development of biotechnology-derived pharmaceuticals (biopharmaceuticals), vaccines, and cell-based therapies has placed the discipline of Immunology as a cornerstone to delineate test article immunotoxic or immunomodulatory effects. Studies are conducted in accordance with the United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58, and current International Conference on Harmonisation (ICH) Tripartite Guidelines (S6 and S8) using validated state-of-the-art instrumentation. The Immunology scientists can partner to customize, develop and implement non-GLP methods and protocols as an extension of Sponsors’ discovery objectives.

Our Immunology Department provides comprehensive preclinical immunological assessment for biotechnology-derived pharmaceuticals. Species tested include humans, nonhuman primates, rats, mice, and canines.

Guidelines for immunotoxicity assessment involve ICHS6, ICHS8, and OPPTS 870.7800 repeat-dose toxicity studies in two species, clinical observations, clinical pathology, body and organ weights, and histopathology. If changes are observed in any of these parameters that suggest immunotoxicity, follow-up studies are performed using a weight of evidence approach, scientific basis. Additional immunotoxicity assessments may be required depending upon the immunopharmacology and clinical indication of the test article. The Immunology department at MPI Research is equipped to handle testing as necessary, including:

• Immunogenicity testing (screening, characterization,and Nab assays)
• PK testing
• Biomarker assessment
• TDAR determination of primary and secondary antibody (IgM and IgG) responses to a T-cell dependent antigen (KLH or SRBC)
• Peripheral blood leukocyte immunophenotyping by flow cytometry
• Natural Killer cell activity by flow cytometry
• Multiplexing (Meso-Scale Discovery and Bio-plex 200Luminex)

Services/Capabilities

General

• Method feasibility, development, and validation for custom assays
• Immunotoxicity assessment
• Cell-based assay method development
• Peripheral blood mononuclear cell (PBMCs) isolation and culture

Immunoassay and Immunogenicity

• Customized development and GLP-validation of bioanalytical methods for detection and quantitation of biologics using ELISA, electrochemiluminescence (Meso-Scale Discovery), Homogenous time-resolved fluorescence (HTRF) and Luminex platforms
• GLP-validation of commercial immunoassays, as well as custom-built assays
• Customized development and GLP-validation of cell-based assays including flow cytometric methods; immunogenicity and PK assays

Flow Cytometry and Cellular Immunology

• Immunophenotyping of peripheral blood leukocytes in various species (rat: Sprague Dawley, Fischer 344 and Wistar; canine [Beagle], nonhuman primate, and mouse [C57/BL6, CD-1, Balb-C])
• Peripheral blood and splenic T regulatory cell characterization (murine, rat, and non-human primate)
• Natural Killer cell activity assay (rat and non-human primate)
• Splenocyte proliferation assay
• Phenotypic characterization of different cell types
• Intracellular cytokine and/or biomarker quantitation identification (Th1, Th2 characterization by intracellular markers)
• Customized assay development and GLP-validation
• Complement assessment in nonhuman primates
• Phagocytosis assays by flow cytometry in rat and nonhuman primate

Immunology services are provided at MPI Research’s 2,400 square-foot laboratory. The lab is equipped with two Beckman Coulter cytomics FC 500 MPL flow, clinical grade cytometers, SPECTRAmax spectrophotometers with fluorescence, luminescence and HTRF functions, Wallac 1470 Wizard Gamma Counter (PerkinElmer), Meso-Scale Discovery Sector Imager electrochemiluminescence instruments, Bio-plex 200 Luminex systems, cell culture rooms, and space for sample processing, using validated immunology assays.

For more detailed information about the immunological services offered by MPI Research, please contact immunology@mpiresearch.com or 269.668.3336, Ext. 1869.

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