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Driving stem cells to the clinic
CARLSBAD, Calif.—Life Technologies Corp. has signed a collaborative research agreement and related license with Harvard University, giving Life Technologies exclusive rights to develop a panel of characterization assays designed to rapidly evaluate human pluripotent stem (hPS) cells potentially useful in many discovery and translational research applications.
The collaborative research agreement is for 16 months with options to extend it, according to Dr. Chris Armstrong, general manager and vice president of primary and stem cell systems at Life Technologies, a global biotechnology company providing products and services for scientific research, genetic analysis and applied sciences.
The license, which expands Life Technologies' growing portfolio of stem cell research products and deepens its commitment to customers in the field, is based on a panel of assays developed by Dr. Alex Meissner, associate professor in the Department of Stem Cell and Regenerative Biology at Harvard University, and is being further studied and validated in collaboration with Life Technologies. The panel, which will be offered on Life Technologies' semiconductor sequencing and PCR-based genetic analysis platforms, is designed to help overcome major hurdles that impede stem cell technology from delivering on the promise of disease modeling and ultimately moving into the clinic.
"Stem cell researchers spend 35 percent of their time on characterization for evaluating pluripotency—the potential for induced pluripotent stem (iPS) cells to differentiate into any cell type—because many of the techniques have not been standardized," Armstrong explains. "They are costly and produce ambiguous results. There is a need to consistently characterize and do quality-control checks on the cells being produced. Because the research is attractive, a lot of cells are being produced, and they require a lot of characterization."
In fact, BioInformatics LLC estimates the global stem cell characterization market at $30 million per year, while the overall market for the stem cell research tools is approximately $1 billion. It's growing at a low double-digit percentage, according to Armstrong.
Pluripotent stem cells may be used to understand where diseases originate. If high-quality starting materials can be differentiated for cells of interest, researchers can see what causes disorders at the cellular level. In regenerative medicine, researchers can take a patient sample, correct it and reintroduce it into the body.
"There's a lot of opportunity," Armstrong says. "With the discovery of iPSC technology, researchers can potentially make any cell type in the body from any human being on the planet."
Life Technologies surveyed the academic community and found that Meissner's laboratory had "a deep understanding of the molecular networks important in pluripotency and the associated capabilities that would help create assays that we wanted to bring to the research community," says Armstrong. By measuring gene activity in iPS cells against the study's gene expression range, his lab was able to accurately score cells for their potential to differentiate into particular cell lineages.
Meissner, whose study was published in the journal Cell in 2011 and identified a range of expression levels among key genes associated with pluripotency, says he believes that "stem cell research and genomics have rapidly advanced in parallel over the past few years." He adds, "Combining both fields of study is enabling more effective and standardized ways of characterizing pluripotent cells and, therefore, greatly improving efficiency and the application of iPS cells."
The collaboration with Harvard is the third major license agreement in less than a year for Life Technologies' Primary and Stem Cell Systems group. In June 2012, the company retained the non-exclusive global rights from iPS Academia Japan for its iPS cell patent portfolio, enabling Life Technologies to expand its range of products and services. That same month, Life Technologies entered into a partnership with Cellular Dynamics International, a producer of human cells derived from (iPS) cells, to commercialize a set of new products optimized to consistently develop and grow human iPS cells.
Also in 2012, Life Technologies introduced a DNA sequencing technology in which scalable, low-cost semiconductor manufacturing techniques were used to make an integrated circuit to directly perform non-optical DNA sequencing of genomes. It enabled researchers to obtain sequence data by directly sensing the ions produced by template-directed DNA polymerase synthesis using all-natural nucleotides on the massively parallel semiconductor-sensing device or ion chip, thus enabling low-cost, large-scale production and scaling of the device to higher densities and larger array sizes.
"Isolating and characterizing pluripotent stem cells efficiently is critical to enhancing the use of this technology in the market, and will be a foundational component of driving stem cell technology to the clinic," Armstrong says. "Scientists can use them to understand disease and use modified cells as therapy. We're deploying technologies in the company to support scientists in those endeavors."