Toxicology

Southern Research maintains a science-driven, client-focused approach in providing GLP-compliant preclinical safety assessments to commercial and government clients, offering more than 40 years of experience with small molecules and more than 15 years of experience with biologics, including vaccines. As an integral part of our comprehensive toxicology services, Southern Research also offers specialized expertise in developmental and reproductive toxicology as well as immunotoxicology.

The diverse scientific expertise of the Southern Research staff provides multidisciplinary capabilities to support both standard and complex studies of a broad spectrum of test articles. Southern Research study directors are well versed in applicable regulations for evaluation of small molecules and biologics, including vaccines, and they have extensive experience in designing studies and testing programs that meet FDA requirements for regulatory submission. A hallmark of the Southern Research toxicology program is the capability to formulate customized study protocols to meet clients' needs at any point in their preclinical assessment programs.

Our toxicology program includes the following areas of expertise.

Safety Testing of Biologics and Vaccines

Southern Research leverages more than 15 years of experience in the safety testing of biologics, including vaccines, providing customized toxicological assessments to assist clients in the successful development of their therapies. Our diverse capabilities include GLP-compliant single and multiple-cycle toxicity, biodistribution, and immunogenicity studies of a variety of test articles, including gene therapy and oncolytic viral vectors (e.g., adenovirus, lentivirus, HSV, and HPV), monoclonal antibodies, peptides, plasmid DNA vaccines, and other.

Developmental and Reproductive Toxicology

The Southern Research Developmental and Reproductive Toxicology (DART) program - a core component of our preclinical toxicology services - offers clients a range of specialized assessments to determine a compound's effects on reproductive function and developmental outcomes. Led by a developmental and reproductive toxicologist with 15 years of experience that spans the pharmaceutical and chemical industries, our program features state-of-the-art laboratory facilities and equipment for the design and execution of a range of study types.

Immunotoxicology

Southern Research provides assessments of changes indicative of immune system effects as part of standard toxicology studies in both clinical pathology and anatomic pathology. Our immunotoxicology program - developed as a complement to these core services - provides expanded, specialized immunologic assessments including immunophenotyping and assays to measure the T-cell dependent antibody response and natural killer (NK) cell activity.

Advanced Facilities and Equipment

• Biosafety level 1 (BSL-1) through biosafety level 3 (BSL-3) containment facilities
• Provantis 8^TM software system for capture of in-life activities, developmental and reproductive toxicology, clinical pathology, and anatomic pathology data
• Edstrom WATCHDOG^® Vivarium Management System for automated environmental monitoring of animal facilities
• AAALAC-accredited facility

Supporting Programs and Services

• Toxicokinetics and pharmacokinetics (ADME/PK)
• PCR
• Bioanalytical Services/BAS
• Formulations
• Clinical pathology
• Anatomic pathology
• Surgical services
• Project management
• BSL-1 through BSL-3 facilities
• Veterinary services and animal care

Study Options

• Test Article Categories
• Small molecule (pharmaceuticals, industrial chemicals, environmental contaminants)
• Biologics
• Viral vectors including vaccines, oncolytic vectors, adenovirus, adeno-associated virus (AAV), herpes simplex virus (HSV), and lentivirus
• Plasmid DNA vaccines
• Monoclonal antibodies
• Virus-like particles
• Proteins, peptides, and fusion proteins
• Nutraceuticals and botanical extracts
• Nanoparticle-encapsulated drugs
• Routes of Administration
• Oral (gavage, diet, or capsule)
• Parenteral
• Intravenous
• Subcutaneous
• Intradermal
• Intramuscular
• Intraperitoneal
• Dermal
• Rectal
• Intranasal
• Intraarticular
• Intravesical
• Intracranial, intracerebral, or other brain regions
• Species
• Mouse
• Rat
• Cotton rat
• Hamster
• Rabbit
• Ferret
• Mini-pig
• Dog
• Nonhuman primate
• Specialized Models
• Immunocompromised animals
• Tumor-bearing animals
• Models of infectious disease
• Study Types/Durations
• Acute
• Subchronic
• Chronic
• In utero
• Carcinogenicity
• Embryo-fetal development
• Male/female fertility
• Multigeneration reproduction

Publications