Monoclonal antibody therapeutics represents a billion dollar industry, with their uses ranging from treating solid-organ tumors to autoimmune diseases. An exciting new era of therapeutic drug monitoring, monoclonal antibody therapeutics also bring new complications for the clinical laboratory. Unique metabolic pathways, uncertain therapeutic ranges—and the possibility of the monoclonal antibodies themselves being targets of the immune system—all converge on the need to better understand this fast growing area of laboratory medicine.

If you haven’t kept up with all the progress in therapeutic monoclonals, you’ll want to learn more during today’s afternoon short course, “Clinical and Laboratory Aspects of Monoclonal Antibody Therapeutics.” Melissa Snyder, PhD, Daniel Mytych, PhD, and Julio Delgado, MD, will ensure you are up-to-date on the latest developments. From the basics of therapeutic antibodies themselves, to their use as therapies and their measurement in the laboratory, the three speakers will cover all the aspects needed to truly appreciate these one-of-a-kind therapeutics.

Numerous significant advancements in science as well as several Nobel Prizes have laid the groundwork toward the development of monoclonal antibody therapeutics. The concept of a therapeutic molecule that specifically targeted the cause of a disease extends well past the availability of a personal, versatile countertop magician (a.k.a, the Magic Bullet), to the beginning of the 20th century and the development of a treatment for syphilis. Fast-forward nearly a century through the development of hybridomas and the humanization of antibodies to reach the present with 34 monoclonal antibodies approved for use by the FDA.

Monoclonal antibody-based treatment of cancer has been established as one of the most successful therapeutic strategies for hematologic malignancies and solid tumors. In addition, a better understanding of the underlying mechanisms and therapeutic targets has made monoclonal antibody treatment an ideal strategy for several autoimmune diseases such as inflammatory bowel disease and even rheumatologic disorders. But with great power comes great responsibility, and the laboratory is poised to play a pivotal role in the continued success of monoclonal antibody therapeutics.

These therapies are not cheap, and the possibility that the body will respond by generating anti-drug antibodies underscores the need for the laboratory to accurately measure the drug and the presence of anti-drug antibodies.  But the detection and quantitative measurement of anti-drug antibodies has been difficult. First generation assays had limited clinical utility due to the need for an absence of therapeutic antibody presence in the sample at the time of testing. Other techniques include radioimmunoassays and homogenous mobility shift assays using high-performance liquid chromatography. Currently, studies evaluating the validation of the results between different assays are lacking, making a true apples-to-apples comparison problematic.

Anyone in laboratory medicine will want to keep a close eye on this emerging area. As more monoclonal antibodies enter clinical use, the role of the laboratory will undoubtedly expand as well.