A general process for the development of peptide-based immunoassays for monoclonal antibodies.

Purpose: Monoclonal antibodies (mAb) are an important and growing class of cancer therapeutics, but pharmacokinetic analyses have in many cases been constrained by the lack of standard and robust pharmacologic assays. The goal of this project was to develop a general method for the production of immunoassays that can measure the levels of therapeutic monoclonal antibodies in biologic samples at relevant concentrations.

Methods: Alemtuzumab and rituximab are monoclonal approved for the treatment of B-cell malignancies and were used as a model system.