In Vivo Evaluations

The Southern Research offers extensive experience and expertise in performing compound evaluations and immunogenicity studies in various animal model systems, including nonhuman primates. We work closely with our clients in developing study designs and protocols, with full biostatistician support if needed. In addition, the study protocol and standard operating procedures (SOPs) are designed to meet or exceed the requirements of the United States Food and Drug Administration's regulations regarding Good Laboratory Practices, 21 CFR Part 58 (GLP). Studies are conducted in accordance with the study protocol and can be executed under non-GLP or GLP compliance. For clients requiring GLP-compliant evaluations, our on-site Quality Assurance Unit (QAU) is available for auditing critical phases, study data, and reports.

Diverse Testing Capabilities

We offer in vivo testing models for numerous viral agents, including HIV/AIDS. Recent studies involving SIV/SHIV have focused on mucosal transmission models for evaluating the efficacy of topical microbicides, vaccine development, and adjuvant activity analysis. In addition, we have developed capabilities to test multi-drug therapeutic regimes in SIV/SHIV-infected macaques. Additionally, compounds active against HIV can be evaluated in the HIV/SIV/SHIV nonhuman primate model using macaques; compounds and virus can be administered using a variety of methods and routes. Quantification of results may be performed using a variety of methods, including viral load determination by quantitative PCR, quantitative and bulk co-cultivation assays, plasma co-cultivation assays, antigen and antibody detection assays, lymphocyte proliferation, intracellular cytokines, and flow cytometry, as well as hematology and clinical chemistry evaluation.

Our comprehensive capabilities include:

Efficacy Models

• Protocol development
• Animal procurement from approved vendors
• Product evaluation studies
• Safety
• Immunogenicity via multiple immunization routes
• Dose-ranging
• Vaccine/drug combination
• Highly active antiretroviral therapy (HAART) in the SIV/SHIV NHP model
• Correlates of protection
• Challenge dose preparation and optimization via parenteral and mucosal routes
• BSL-2 and BSL-3 containment
• Statistical plan

Core Support Services

• Antibody detection by ELISA and Western blots
• Fine analysis of antibody responses using synthetic peptides to identify linear immunogenic B-cell epitopes
• Assess functionality of binding antibodies using neutralization assays
• Immunophenotyping and detection of activation markers by flow cytometry
• Radioactive and non-radioactive-based proliferation assays
• T-cell epitope mapping
• Detecting Th1 and Th2 cytokine profiles in T-lymphocytes subsets by intracellular flow cytometry, ELISPOT, ELISA, and multiplexing techniques
• State-of-the-art tetramer technology using MHC/peptide tetrameric complexes to directly measure CD8+ cytotoxic T-lymphocytes (CTL)
• Studies on apoptosis
• Assays to detect early signal events during T-cell activation, e.g. Calcium Mobilization Assay
• Determination of viral load by qRT-PCR and infectivity assays

Other Support Services

• Full-service clinical pathology and anatomic pathology
• GLP toxicology and bioanalytical sciences (BAS)
• Toxicokinetics and pharmacokinetics (ADME/PK)
• Assay development
• Quality assurance