Implications of Monoclonal Antibody Therapeutics Use for Clinical Laboratory Testing.

Abstract

Monoclonal antibody therapeutics (MATs) represent a rapidly expanding class of biological drugs used to treat a variety of diseases. The widespread use of MATs increasingly affects clinical laboratory medicine. This review provides an overview of MATs currently approved for clinical use in the US, starting from basic biology of antibodies to the engineering, pharmacokinetic and pharmacodynamic properties, nomenclature, and production of MATs. Immunogenicity and the production of antidrug antibodies (ADAs) play a major role in loss of therapeutic response and the development of treatment failure to certain MATs. Laboratory-based monitoring for MATs and detection of ADAs represent emerging needs for optimizing the use of MATs to achieve the best outcomes at affordable cost. In addition, the increased use of MATs affects clinical laboratory testing by interference of MATs with clinical laboratory tests across different areas of laboratory medicine, including histocompatibility, blood bank, and monoclonal protein testing. The number of MATs is rapidly growing each year to address previously unmet clinical needs. Laboratory monitoring of MATs and detecting ADAs represent expanding areas of laboratory testing. Test-based strategies allow for treatment optimization at the level of the individual patient, thus providing a personalized medicine approach. In addition, clinical laboratories must be aware that the increasing use of MATs affects laboratory testing and be ready to implement methods to eliminate or mitigate interference with clinical tests.