Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys


This work was conducted to develop and validate (fit-for-purpose, FFP) an efficient means for pharmacokinetic (PK) analyses of large molecule drugs composed in part, or in whole, of human IgG. PK behavior of large molecule drug candidates in experimental animals is often a determination factor in the selection of which candidate(s) to pursue. Analysis of serum or plasma for the presence of such drugs can be expensive and time consuming, especially if an analytical method needs to be developed and validated for each candidate in a series of candidates. Accordingly, we propose to use the present method of analyzing for the presence of human IgG antigenic determinants in the plasma of mice, rats, or monkeys, subsequent to injection of human therapeutic antibodies, or constructs containing any part of the human IgG molecule