With the
effective treatment of immunosuppressive
diseases as a pressing issue in today's medical
arena, the importance of determining the
potential effects of agents on the immune
system is underscored. In utilizing the Immunology
services offered by MPI Research, Sponsors
can study the potential adverse effects on
the immune system resulting from exposure
to pharmacological, chemical, or biological
materials as part of their overall preclinical
or early clinical safety assessment of a
compound.
Immunological, immunoassay, and flow cytometry procedures as well as a host of other techniques are used to support a wide range of studies that are integral components of global registrations of pharmaceutical, biotech, and chemical compounds. MPI Research has a large and well-equipped laboratory that includes GLP-validated flow cytometers, in vitro cell culture equipment and immunoassay instruments. We have established SOPs and validated methods, protocols in place.
General guideline requirements for immunotoxicity
assessment include:
- Repeat-dose toxicity studies in two
species
- Clinical observations
- Clinical pathology
- Body and organ weights
- Histopathology
If changes are observed in any of these parameters that suggest immunotoxicity, then follow-up studies are required on a case-by-case, scientific basis. Additional immunotoxicity assessment is required by some regulatory agencies, and MPI Research is equipped to handle whatever immunotoxicological testing is necessary, including:
- Determination of primary and secondary
antibody (IgM and IgG) responses to a T-cell
dependent antigen (KLH) by ELISA
- Peripheral blood leukocyte immunophenotyping
by flow cytometry (rat, dog, and nonhuman primates)
- Natural killer cell activity by flow
cytometry (rat and nonhuman primates)
- Immunogenicity testing
- Biomarker assessment
Services/Capabilities
- Immunotoxicity assessment
- Preclinical and clinical sample analyses
- Immunology and immunotoxicity method
development
- Cell-based assay method development
- Peripheral blood mononuclear cell (PBMCs)
isolation and culture
- Delayed-type hypersensitivity (DTH)
assay
- Local lymph node assay (LLNA)
- Customized assays
- Guinea pig sensitization test
Immunoassay and Immunogenicity
- Customized development and GLP-validation
of bioanalytical methods for detection
and quantitation of biologics using ELISA
and electrochemiluminescence platforms
(BioVeris and Meso-Scale Discovery)
- GLP-validation of commercial immunoassay kits for bioanalyses
- Immunogenicity assay development and validation
- Customized development and GLP-validation of cell-based assays including flow cytometric methods
- Biomarker assessment
Flow Cytometry and Cellular Immunology
- Immunophenotyping of peripheral blood leukocytes in various species (rat: Sprague Dawley, Fischer 344 and Wistar; dog and nonhuman primates)
- Natural killer cell activity assay (rat and nonhuman primates)
- Splenocyte proliferation assay
- Phenotypic characterization of different cell types
- Intracellular cytokine and/or biomarker quantitation
- Customized assay development and GLP-validation
- Apoptosis
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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