Antibodies are proteins produced by the immune system in response to other proteins, which are called antigens. In the clinical context, antigens are usually associated with unwanted invaders. Researchers can use these antibodies in a similar fashion to detect antigens in biological samples that may be tied to cancer.

Though antibodies are essential in research and diagnostic laboratories around the world and thousands are available commercially, "the majority of these antibodies are poorly characterized and their quality is unreliable," notes Dr. Henry Rodriguez, who directs NCI's Clinical Proteomic Technologies for Cancer (CPTC) program.

Two years ago, NCI sponsored a workshop to determine what reagent resources were needed by the cancer research community to facilitate the identification of proteins and peptides of interest. The unanimous message was that one of the biggest bottlenecks is a lack of well-characterized antibodies.

"As industry and academia invest significant resources in the promise of proteomics and ultimately molecular-based tools, well-characterized antibodies will be vital to advancing these disciplines," says Dr. Rodriguez. "This is especially true of proteomics, where an antibody can be used to recognize a unique protein in the midst of millions of other proteins that the human proteome comprises."

The Antibody Characterization Laboratory will be part of NCI-Frederick's Advanced Technology Program (ATP), which includes teams working on protein analysis, structure, and molecular imaging. "We have quite a broad program with a variety of different protein characterization technologies," says Dr. Tim Harris, who directs ATP. When the antibodies start to arrive in Frederick in the coming months, Dr. Gordon Whiteley will lead the characterization team.

The CPTI pipeline starts with the Argonne National Laboratory, where cancer-related proteins are being produced. Later this year, private laboratories will be contracted to manufacture three monoclonal antibodies for each of these proteins and send these to NCI-Frederick for standard operating procedures-driven characterization. Promising antibodies will then travel to the Human Protein Atlas project in Stockholm, Sweden, and to the Harvard Institute of Proteomics for further analysis. All characterization data will be accessible to the scientific community through a Web site, with antibodies and hybridoma cells distributed by the Developmental Studies Hybridoma Bank at the University of Iowa.

"This program will spur the development of resources that accelerate biomarker discovery and validation, translational research, molecular diagnostics, and therapeutic monitoring," says Dr. Rodriguez. "I'm convinced that when this happens, we will have a solid foundation on which to create a real impact with proteomics in cancer."

Plans for the pipeline were announced last month at the first CPTI annual meeting, where NCI Director Dr. John Niederhuber said that progress in clinical proteomics will require technological advances similar to those that have enabled recent progress in genomics. He added that the efforts of the CPTC will contribute fundamentally to the early detection and treatment of cancer, and affect all diseases.