White Paper: Utility and Application of the VeriKine Cynomolgus/Rhesus IFN Alpha Serum ELISA

Content:

• Non-human primate in pre-clinical research
• IFN-α and TLR therapeutics
• IFN-α and hepatitis infections
• IFN-α and rheumatoid arthritis
• Benefits of the VeriKine Cynomolgus/Rhesus IFN-α ELISA

Abstract

Although non-human primates (Cynomolgus and Rhesus macaques) are used as important pre-clinical models for testing the safety and efficacy of immunomodulatory agents, such as Toll-Like Receptor (TLR) agonists and antagonists, in a variety of diseases, research is currently hindered by the limited availability of reagents for sensitively detecting interferon-alpha (IFN-α) production in these species. IFN-α is produced by many cell types, including plasmacytoid dendritic cells and macrophages, in response to TLR ligation by bacterial and viral components, and plays pivotal roles in both protective and pathologic immunity. Clinically, maintenance of serum IFN-α levels within a range that is advantageous for limiting viral infections, while simultaneously avoiding the onset of autoimmunity, is crucial. As an example, for autoimmune diseases such as rheumatoid arthritis (RA), antagonists to TLRs 7 and 9 are being developed as novel therapeutics to dampen excessive IFN-α production. In contrast, TLR 7 and 9 agonists are being evaluated for their ability to induce IFN-α and enhance protective immunity against Hepatitis C viral infection. However, both of these strategies necessitate carefully monitoring of IFN-α levels to protect against the development of immunocompromise or detrimental side effects. Use of pre-clinical macaque models therefore affords the unique opportunity to test novel therapeutics for efficacy, potency, safety, toxicology, and off-target side effects prior to beginning Phase I trials in humans. In the absence of a rapid, reliable method for detecting IFN-α in macaque samples, researchers are forced to use labor- and time-intensive biological activity assays, resulting in increased project costs and lengthened evaluation periods. In response to these needs, PBL has recently developed a simple, sensitive sandwich ELISA that accurately detects bioactive levels of macaque and other non-human primate IFN-α. Potential applications of the VeriKine Non-Human Primate Serum ELISA kit (catalog # 46100-1) will be discussed.

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