Recent guidelines by U.S. and European regulatory agencies regarding immunosuppression or immune response modification by many pharmaceutical and medical products has illustrated the need for immune function assessment during preclinical testing. MPI Research has always been an industry leader in meeting sponsor needs to comply with changes in the preclinical regulatory environment, and is ready as well in the area of Immunotoxicology. In addition to the standard immunohistochemistry and histopathological evaluations that have been available, complete immunophenotyping, cell based functional assays, such as natural killer function, and ELISA (antibody response to a T cell dependent antigen) assays are available.

FAST Systems, a division of MPI Research, set the industry standard for developing flow cytometry based assays such as immunophenotyping and immune cell function testing with over 16 years of experience in the science of flow cytometry. Immune function in multiple species, including humans, nonhuman primates, rats, mice and canines can be evaluated using ELISA or flow cytometry, and can be conducted by MPI Research in support of preclinical or clinical studies. Custom assay development is also available to meet individual sponsor needs.

Marlon Rebelatto, DVM, PhD., ACVP, Director of Immunotoxicology for MPI Research, commented, “Many in our industry think of immunotoxicology as a new discipline, but that is not the case. In reality, what is new is the regulatory agency guidelines and requirements for inclusion in preclinical testing. MPI Research and FAST Systems have been conducting these assessments in both animals and humans for over 16 years, and can meet existing and future regulations regarding the immune function impact of both pharmaceuticals and medical devices. By including flow cytometry or ELISA evaluations in standard toxicology tests, sponsors realize significant saving in time and cost versus conducting these test as stand alone studies later in development. In addition, flow and ELISA may show subtle changes in immune function not evident in standard clinical observations, immunohistochemistry or pathological examines.”

MPI Research exists to provide comprehensive non-clinical research that meets the requirements of pharmaceutical, medical device, animal health and chemical companies as well as governmental agencies as we partner together to bring safer, healthier products to the world. MPI Research employees specialize in a wide variety of scientific disciplines including toxicology, pharmacology, metabolism, pathology, clinical pathology, reproductive and developmental biology, veterinary science, neuroscience, experimental therapeutics, immunotoxicology, analytical chemistry, computer science, regulatory science, and statistics.

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