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 NHP)
- Natural killer cell activity by flow cytometry (rat and
NHP)
- 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
NHP)
- Natural killer cell activity assay (rat and NHP)
- 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 immunotox@mpiresearch.com or
269.668.3336, Ext. 1869.
Home | Services/Capabilities
|
