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NCI Awards Strategic Diagnostics First Round of Funding to Develop Antibodies

The National Cancer Institute has awarded a contract to Strategic Diagnostics to develop monoclonal antibodies as the first step in the institute’s effort to raise the bar on antibody characterization and development.
As the recipient of the first round of what the NCI anticipates will be a series of funding rounds for the initiative, Strategic Diagnostics will produce three antibodies for each of 42 antigens identified by the institute, which will then be characterized by NCI’s antibody-characterization laboratory established at its Frederick, Md., site last year.
The antigens for which antibodies are being produced in this round include cystatin B, fibroblast growth factor 1, interleukin 1 alpha, and squamous cell carcinoma antigen 1. The antibodies are anticipated to be released during the fall, Henry Rodriguez, director of NCI’s Clinical Proteomic Technologies for Cancer program, told ProteoMonitor.
In addition to this first funding round, NCI anticipates another RFP during the summer for the production of antibodies against 40 to 50 additional antigens, Rodriguez said. The short-term goal of the antibody initiative is to produce antibodies for 250 antigens within two years, he said.
The institute is leaving open the possibility of an even greater scope longer term.
“If there are additional antigens that we think the community will have an interest in and [which] will serve as a good resource as a reagent, that’s something that we might contemplate to bring them into this program,” he said.
Both the NCI and Strategic Diagnostics declined to disclose the cash amount of the contract.
The protocols that Strategic Diagnostics will follow to produce the antibodies will be very similar to traditional antibody development, “but its considerable scale and quality metrics” distinguishes this effort from other antibody work the company has done for its custom-antibody clients, said Damon Hostin, manager of marketing strategy and development for Strategic Diagnostics.
Rodriguez said the company was chosen from among several firms that competed for the contract by Science Applications International Corp., which subcontracted with NCI. 
NCI is “embarking upon hundreds and hundreds of antibodies,” Hostin said. “These are meant to be reference antibodies so we need to ensure that they are a very high quality. There’s going to be a tremendous amount of characterization that’s going to go into these by the NCI, but everything is for naught if we do not work with them closely to select the antibodies that they are going to characterize.”
While Strategic Diagnostics will do the initial characterization of the antibodies with standard ELISAs, the bulk of the characterization will be carried out by NCI-Frederick. In addition to ELISAs, other technologies that will be used include Western blots, surface plasmon resonance, immunohistochemistry, immunoprecipitation, immunofluorescence, and immuno-mass spectrometry.

“Each antibody will have not just data for all of those techniques but the protocol to replicate it and the controls, just an amazing standardized resource to compare things to and use, instead of everyone using different reagents.”

NCI is also in negotiations with the Royal Institute of Technology in Stockholm, Sweden, which runs the Human Protein Atlas, and Harvard Medical School’s Institute of Proteomics to further characterize the antibodies.
“Each antibody will have not just data for all of those techniques but the protocol to replicate it and the controls, just an amazing standardized resource to compare things to and use, instead of everyone using different reagents,” Hostin said.
Strategic Diagnostics sees the contract as validation of its custom antibody expertise, which generated about half of the company’s revenues of $27.2 million last year, Hostin said. Among its clients for its custom antibody production business are the top-five diagnostic firms and nine of the top-15 pharmaceutical companies.
“This is third-party validation of what we put together,” he said. “We have our sales people, who can get out and give sales presentations all day, or you can show this press release, and people can say ‘Oh, OK, good.’
“So it’s very important strategically to the company to show that we really are offering some of the highest quality antibody development anywhere,” Hostin said.
Poor Character, Poor Antibody
NCI’s antibody project, announced late last year, is part of the institute’s five-year, $104 million Clinical Proteomic Technologies Initiative for Cancer program to develop new proteomics tools and technologies for cancer research. A component of CPTI is the Clinical Proteomic Reagents Resource Initiative, under which the antibody project is being developed [See PM 11/29/07].The project comes also as the proteomics field increasingly is pushing for better antibodies. In 2005, the NCI held a workshop with proteomics researchers to discuss bottlenecks in the field, during which the dearth of high-quality antibodies was identified as one of the most significant roadblocks.
While many companies sell antibodies, many of them target the same antigens, and according to some estimates, antibodies exist for only about 20 percent of known human targets. The other issue is that most of the antibodies that are commercially available are of such questionable quality that they don’t always work the way researchers need them to.
The research community is increasingly bringing the issue to the forefront. Last summer, Joshua LaBaer, head of Harvard’s proteomics institute, called for an ambitious, long-term, large-scale antibody-generation effort [See PM 06/28/07]. In the area of antibody microarrays, in particular, the dearth of high-quality antibodies is believed to be holding the technology back.
Incrementally, though, the field is turning its attention to improving antibody quality. The Human Protein Atlas, spearheaded by Matthias Uhlén, currently has more than 3,000 antibodies and 2.8 million images.
Recently, Atlas Antibodies, the commercial arm of HPA, inked a deal with Sigma-Aldrich to sell 1,800 highly characterized antibodies developed by HPA, with the eventual goal of making 22,000 such antibodies commercially available. In addition to characterization by ELISAs and Western blots, each antibody will undergo immunohistochemistry [See PM 02/14/08].
Such an industry-driven effort is exactly what NCI hopes to see in the future, regardless of its own antibody initiative, Rodriguez said.
“When I read things about Sigma trying to raise the characterization of their own products, personally, I just think that does a huge service for the research community. Ultimately, that’s what we all want to produce,” he said.
Once characterized and produced, NCI’s antibodies will be made available through the Developmental Studies Hybridoma Bank at the University of Iowa.

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