The analysis of immune system effects is an increasingly critical component of the comprehensive preclinical assessment of drugs and biologics, due in part to growing regulatory requirements from the FDA. Southern Research provides assessments of changes indicative of immune system effects as part of standard toxicology studies in both clinical pathology (hematology, clinical chemistry) and anatomic pathology (gross pathology, organ weights, histology). As a complement to these integral toxicology services, our immunotoxicology program was developed to provide expanded, specialized immunologic assessments including immunophenotyping and assays to measure the T-cell dependent antibody response and natural killer (NK) cell activity. We routinely perform immunotoxicology services for clients in the biotechnology, pharmaceutical, medical device, and chemical industries. Based on our decades of experience in immunology and toxicology, we offer unique expertise to conduct immunotoxicologic assessments in support of regulatory filings for IND packages.

Using validated, state-of-the-art instrumentation, immunotoxicology studies at Southern Research are conducted in multiple species in compliance with U.S. FDA Good Laboratory Practice (GLP) regulations and their European and Asian equivalents. Our study directors work closely with clients to design optimal study protocols that meet our clients' specific needs. As such, we offer extensive experience in custom assay development when needed and also have validated many of the standard immunotoxicology assays shown below:

Initial Evaluations

• Assessment of antibody production by:
• Plaque-forming cell (PFC) assay using sheep red blood cells (SRBC)
• SRBC ELISA
• Natural killer (NK) cell assay
• Immunophenotypic analysis by flow cytometry

Additional Studies

• Macrophage functions
• Cytokine/chemokine profiles (e.g., Th1/Th2 and markers of inflammation)
• Bone marrow progenitor cell assays in multiple species (CFU-GM, CFU-E, BFU-E, CFU-GEMM)

Publications