Genetic Engineering & Biotechnology News

DEC 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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26 | DECEMBER 2017 | | Genetic Engineering & Biotechnology News Translational Medicine 3D Bioprinting Continued from page 24 has developed 3D-printed, vascularized skin grafts that have superior qualities to currently existing grafts. He described some of his results in his presentation, "3D Printing of Full-Thick- ness Vascularized Human Skin Grafts." His group has designed the grafts and tested them to treat wounds on mice. According to his re- search, the vascularized grafts integrated into the wound site better than avascularized grafts. Dr. Karande said that the use of vascular- ized skin grafts in studies offers many advan- tages over conventional skin grafts. Because the vascular system is present, processes such as penetration of a drug or toxin into the skin can also be studied. The ink used for printing is a mixture of cells including fibroblasts, epithelial cells, and other components of skin, such as colla- gen and other matrix molecules. Dr. Karande said it was a challenge developing the right technique to print and grow the skin and vasculature together. The method used was to print cells in three compartments in a layer-by-layer fashion, with the vasculature mapped out. "We had to put a lot of time in[to] fine-tuning and optimizing all of those conditions," said Dr. Karande. Dr. Karande said that their studies showed that the graft begins to be populated by host cells and that the vasculature forms connec- tions with host vasculature. "Our guess is that the entire graft would be repopulated with host cells," said Dr. Karande. "We don't know how long [this would take]. Our sense would be a couple of months." Focusing on Corneal Regeneration The extracellular matrix is the substance surrounding cells that provides the informa- tion needed for organ formation during em- bryogenesis, and during repair and regenera- tion. In her presentation, "Biomimetic Col- lagen-Like Hydrogels: From In Vitro Testing to Regenerative Medicine," May Griffith, Ph.D., a professor at the University of Mon- treal, Canada, describes how cell-free hydro- gel implants made with recombinant human collagen to mimic the extracellular matrix of the cornea were used successfully in clini- cal trials to regenerate human corneas. The implants were fabricated using 3D molding. They represent a potential future applica- tion of 3D-printing technology, if the printer technology can be improved to achieve suf- ficient resolution. According to Dr. Griffith, the resolution range of a 3D printer is in the 10–100 micron range. "What we want to do is have some- thing that's smooth—very, very smooth," she said. That means the resolution would need to be in the submicron range. "For now, it's easier for us to use molds, but what we have been doing is using 3D printing to make some of the holders we're using for surgery." Dr. Griffith said that being able to use 3D printing would allow for more implants per day. Currently, her laboratory is focusing on inks with potential use in 3D printing, and examining the feasibility of the use of both recombinant collagen and short collagen-like peptides for such applications. Collagen-based 3D printing ink would include the creation of skin constructs. Griffith said her group has tested that use with a collaborator. "That works well for tissues that don't need a fine resolution," she said. "It's easier to print large pieces of skin than to mold them." References 1. S.A. Khaled et al., "3D Printing of Tablets Containing Multiple Drugs with Defined Release Profiles," Int. J. Pharm. 494(2), 643–650 (October 30, 2015). 2. T. Xu et al., "Construction of High-Density Bacterial Colony Arrays and Patterns by the Ink-Jet Method," Biotechnol Bioeng. 85(1), 29–33 (January 5, 2004). 3. E.A. Roth et al., "Inkjet Printing for High- Throughput Cell Patterning," Biomaterials 25(17), 3707–3715 (August 2004). Figure 2. Phenotypic appearance (A) liver, (B) pancreas, and (C) cartilage cells in vivo. Photo courtesy of Ali Mobasher Take the search out of research with abm's CRO services Learn more at Gene Editing Cell Engineering Sequencing IHC Staining Viral Packaging Antibody Engineering Custom Services Insights Molecular Diagnostics Thermo Fisher Scientific said it will develop and commercialize its Oncomine Dx Target Test as a com- panion diagnostic for Blueprint Medicines' Phase I BLU-667, with the goal of identifying RET fusions in patients with non-small cell lung cancer (NSCLC). Un- der the collaboration, whose value was not disclosed, Thermo Fisher will also retain rights to commercialize the test globally and will lead all required filings to seek clearance from regional regulatory agencies for the test. Thermo Fisher said the CDx will complement ef- forts to drive enrollment to a Phase I clinical trial by Blueprint Medicines. The company is now recruiting patients for the study, designed to assess BLU-667 in patients with RET-driven NSCLC, thyroid cancer and other advanced solid tumors. Once validation is complete, Thermo Fisher said, it will submit a supplemental premarket approval application to the FDA to expand the clinical claims for its Oncomine Dx Target Test. Expansion of the CDx is part of a strategic plan by Thermo Fisher to develop one multi-gene test ca- pable of screening patients for multiple therapies si- multaneously—a shift from the conventional method of running several, single-biomarker analyses in se- quence to identify tumor profiles. Thermo Fisher's col- laboration with Blueprint Medicines is its second CDx development program with a drug developer. In May, Thermo Fisher agreed to develop and commercialize a next-generation sequencing (NGS) oncology com- panion diagnostic for Agios Pharmaceuticals' Phase III cancer candidate ivosidenib (AG-120). The CDx will be designed to identify isocitrate dehydrogenase 1 (IDH1) mutations in patients with cholangiocarcino- ma, a rare form of cancer that affects the human bile duct system. n Thermo Fisher Scientific Partners with Blueprint Medicines on Cancer CDx

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