Driving stem cells to the clinic

Collaboration enhances characterization of pluripotent stem cells

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CARLSBAD, Calif.—Life Technologies Corp. has signed acollaborative research agreement and related license with Harvard University,giving Life Technologies exclusive rights to develop a panel ofcharacterization assays designed to rapidly evaluate human pluripotent stem(hPS) cells potentially useful in many discovery and translational researchapplications.
The collaborative research agreement is for 16 months withoptions to extend it, according to Dr. Chris Armstrong, general manager andvice president of primary and stem cell systems at Life Technologies, a globalbiotechnology company providing products and services for scientific research,genetic analysis and applied sciences.
The license, which expands Life Technologies' growingportfolio of stem cell research products and deepens its commitment tocustomers in the field, is based on a panel of assays developed by Dr. AlexMeissner, associate professor in the Department of Stem Cell and RegenerativeBiology at Harvard University, and is being further studied and validated incollaboration with Life Technologies. The panel, which will be offered on LifeTechnologies' semiconductor sequencing and PCR-based genetic analysisplatforms, is designed to help overcome major hurdles that impede stem celltechnology from delivering on the promise of disease modeling and ultimatelymoving into the clinic.
"Stem cell researchers spend 35 percent of their time oncharacterization for evaluating pluripotency—the potential for inducedpluripotent stem (iPS) cells to differentiate into any cell type—because manyof the techniques have not been standardized," Armstrong explains. "They arecostly and produce ambiguous results. There is a need to consistentlycharacterize and do quality-control checks on the cells being produced. Becausethe research is attractive, a lot of cells are being produced, and they requirea lot of characterization."
In fact, BioInformatics LLC estimates the global stem cellcharacterization market at $30 million per year, while the overall market forthe stem cell research tools is approximately $1 billion. It's growing at a lowdouble-digit percentage, according to Armstrong.
Pluripotent stem cells may be used to understand wherediseases originate. If high-quality starting materials can be differentiatedfor cells of interest, researchers can see what causes disorders at thecellular level. In regenerative medicine, researchers can take a patientsample, correct it and reintroduce it into the body.
"There's a lot of opportunity," Armstrong says. "With thediscovery of iPSC technology, researchers can potentially make any cell type inthe body from any human being on the planet."
Life Technologies surveyed the academic community and foundthat Meissner's laboratory had "a deep understanding of the molecular networksimportant in pluripotency and the associated capabilities that would helpcreate assays that we wanted to bring to the research community," saysArmstrong. By measuring gene activity in iPS cells against the study's geneexpression range, his lab was able to accurately score cells for theirpotential to differentiate into particular cell lineages.
Meissner, whose study was published in the journal Cell in 2011 and identified a range of expression levelsamong key genes associated with pluripotency, says he believes that "stem cellresearch and genomics have rapidly advanced in parallel over the past fewyears." He adds, "Combining both fields of study is enabling more effective andstandardized ways of characterizing pluripotent cells and, therefore, greatlyimproving efficiency and the application of iPS cells."
The collaboration with Harvard is the third major license agreementin 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 iPSAcademia Japan for its iPS cell patent portfolio, enabling Life Technologies toexpand its range of products and services. That same month, Life Technologiesentered into a partnership with Cellular Dynamics International, a producer ofhuman cells derived from (iPS) cells, to commercialize a set of new productsoptimized to consistently develop and grow human iPS cells.
Also in 2012, Life Technologies introduced a DNA sequencingtechnology in which scalable, low-cost semiconductor manufacturing techniqueswere used to make an integrated circuit to directly perform non-optical DNAsequencing of genomes. It enabled researchers to obtain sequence data bydirectly sensing the ions produced by template-directed DNA polymerasesynthesis using all-natural nucleotides on the massively parallelsemiconductor-sensing device or ion chip, thus enabling low-cost, large-scaleproduction and scaling of the device to higher densities and larger arraysizes.

"Isolating and characterizing pluripotent stem cells efficiently is critical toenhancing the use of this technology in the market, and will be a foundationalcomponent of driving stem cell technology to the clinic," Armstrong says."Scientists can use them to understand disease and use modified cells astherapy. We're deploying technologies in the company to support scientists inthose endeavors."

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