A generic assay for the quantitation of therapeutic human IgG1 antibodies in monkey serum or plasma.

• Specifically detect human IgG1 antibodies in monkey plasma or serum
• Not cross reactive to rhesus or cynomolgus immunoglobulins
• Useful for pharmacokinetic analysis of therapeutic human IgG₁ antibodies in monkeys
• Useful for detecting human IgG1 in mouse or rat plasma or serum

Human therapeutic antibodies have become increasingly common components of early drug discovery and development portfolios in the pharmaceutical and biotech industries. As part of preclinical toxicology assessment of these agents, they are routinely tested in non-human primates, primarily in rhesus or cynomolgus monkeys. In order to assess the pharmacokinetics of the human antibodies in monkey serum, it is necessary to have an assay that is capable of distinguishing the experimentally-introduced human IgG from the endogenous monkey IgG. Cayman’s Human Therapeutic IgG1 ELISA kit is an immunometric assay which can be used to measure human IgG₁ in monkey or rodent plasma and serum without prior sample purification. The standard curve spans the range of 3,3 to 200 ng/ml, with an LLOQ of 3,13 ng/ml. The assay has been validated in serum from cynomolgus monkeys.