A single administration of recombinant human interleukin-12 is associated with increased expression levels of interferon-gamma and signal transducer and activator of transcription in healthy subjects.

The objectives of this study were to assess the safety and tolerability of single doses of 1, 4, and 8 mug of recombinant human interleukin-12 (rhIL-12) administered subcutaneously to healthy subjects. The pharmacokinetics, pharmacodynamics, and pharmacogenomics of rhIL-12 were evaluated. Recombinant human IL-12 was well tolerated in these healthy male and female subjects.

Vailidation of immunoassays for anti-drug antibodies.

Several methods for the detection of an antibody response to a protein therapeutic are described along with their limitations. Emphasis is placed on immunoassays with specific attention to the ELISA format. Potential sources of interference and issues to consider in the design of an anti-drug antibody assay are reviewed.

Identification of human serum interferants in the recombinant P-selectin glycoprotein ligand-1 clinical ELISA using MALDI MS and RP-HPLC.

A colorimetric enzyme-linked immunosorbent assay (ELISA) was developed to detect circulating levels of rPSGL to permit pharmacokinetic analysis of clinical samples. The ELISA is an asymmetric sandwich utilizing a monoclonal antibody pair. Initial validation studies indicated that 57% of normal individuals scored above the limit of detection of the assay.