Toxicology

Immunotoxicology

In response to the growing regulatory requirements from the FDA, Southern Research formed the Immunotoxicology Program to provide contract based research services to the biotechnology, pharmaceutical, medical device, and chemical industries. Our decades long experience in immunology and toxicology provide us unique expertise to support regulatory filings for IND packages.

All studies are conducted in compliance with U.S. FDA Good Laboratory Practice (GLP) regulations and their European and Asian equivalents. Our study directors work very closely with clients to optimally design study protocols to address their needs. We have extensive experience in developing new assays when necessary 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
• KLH ELISA
• Natural killer (NK) cell assay
• Immunophenotypic analysis by flow cytometry

Additional studies

• Macrophage functions
• Cytotoxic T-cell (CTL) assay
• Cytokine profiles (e.g., Th1/Th2)
• Apoptosis
• Cell cycle analysis
• Bone marrow progenitor cell assays (CFU-GM) in multiple species
• Models of host resistance
• Local lymph node assay (LLNA) for contact hypersensitivity