Based on its recent analysis of the stem cell tools and technologies industry, Frost & Sullivan recognizes Vitro Biopharma with the 2014 North American Frost & Sullivan Award for Technology Innovation Leadership. Vitro Biopharma has excelled in the development of tools and technologies to support stem cell research and clinical studies of mesenchymal stem cells (MSCs). The company offers different cell culture media for the maintenance and differentiation of growing MSCs, while simultaneously expanding its product line to include measurement tools and technologies that determine the potency, quality, response, and behavior of MSCs.
Vitro Biopharma produces not only native MSC lines, but also fluorescent-labeled MSC lines that can be utilized in tracking studies and in vivo live cell imaging. The company, in partnership with Hemogenix, Inc., has developed a proprietary read-out system for accurate measurement of cellular ATP content to test cellular functionality. Based on the HALO® assay platform for high-sensitivity analysis of hematopoietic stem cells (HSCs), this technology is one of the most sensitive bioluminescent read-out assays and includes fluorescent and absorbance-based cellular functionality analyses.
Vitro Biopharma has developed a proprietary MSC line culture media, MSC-Gro™, which has been optimized to support growth and differentiation of MSC lines. The major competitive advantages of this media over its peers are increased rate of growth and superior quality and potency of the MSC lines. Studies have shown that yields reach two to three times the number of cells when utilizing MSC-Gro media culture. Moreover, MSC-Gro media formulations can be stored for more than a year at 2 degrees Celsius to 8 degrees Celsius without alterations.
"Diversity is the other important advantage of Vitro's technology. The media allows the user to prepare additional formulations according to the requirements of various primary cells, such as neurons, hepatocytes, and fibroblasts," said Frost & Sullivan Industry Analyst Cecilia Van Cauwenberghe. "The level of serum in the media (serum-containing or serum-free) enables customers to design a broader spectrum of applications. In fact, customers can select the media that suits each application, under liquid or powder formulations."
Beyond commercial products based on stem cell life sciences tools and technologies, Vitro Biopharma is pursuing white space innovation through its proprietary intellectual property tuned to specific inventions and medical applications. It entered into a license agreement for intellectual rights to the production and purification of the pituitary hormone, FSH, to be used in fertility treatments. Similarly, it licensed the rights for the use of a stem cell line for the treatment of infertility. The company is advancing toward the design of a new cell reprogramming technique, with a pending patent application related to novel methods for generation of induced PSCs (iPSCs) from adult stem cells (ASCs).
Currently, Vitro Biopharma is commercializing a series of stem cell-based assays for osteoporosis drug discovery and discovery of stem cell activation agents through assays of ASC proliferation, migration and reprogramming. Among its most relevant services is the customized biomarker panel analysis to quantify the levels of multiple biological molecules in biological samples. Indeed, under its new business perspective, the assay of human serum samples collected from patients from multiple European clinical treatment centers could make the company a leading provider of serial bio-analytical tools and technologies, not only in North America, but also in Central Europe.
Vitro Biopharma is also working on accelerating healing of bone fractures using MSCs and strengthening bones by activating certain protein signals and molecules. Although optimal signaling of pathways to activate MSCs with the goal of repairing or regenerating bone tissue is still under development, preliminary studies demonstrate significant potential for the creation of new drugs to treat osteoporosis. In fact, the company recently launched its initial line of osteoblasts derived from human MSCs for use in drug discovery and development.
Meanwhile, Vitro Biopharma is aligning its scheduled stages of clinical trials to test mobilization of endogenous stem cells in the treatment of traumatic brain injury and autism spectrum disorders (ASD). For this condition, pre-clinical research strongly suggests that activation of certain biochemical pathways increases stem cell proliferation, migration, and regenerative performance. Vitro Biopharma's approach eliminates stem cell transplantation, while providing a non-controversial, cost- and time-effective alternative to the current methodologies of competitors.
"Vitro Biopharma's technology platform allows generation of iPSCs from ASCs, including MSCs and other subclasses, avoiding the utilization of transfection mechanisms through environmental conditions and small molecules to induce the expression of some reprogramming factors through promoter activation," noted Van Cauwenberghe. "The utilization of ASCs, including MSCs, represents a powerful, efficient, and safe alternative to ESCs derived from embryos."
Vitro Biopharma's business strategy involves the participation of biopharmaceutical firms, large distributors, and contract research organizations (CROs). One of the most successful decisions of Vitro Biopharma has been its merger with Neuromics Inc. to accelerate growth in the near term. The former's research products are primarily focused on ASCs and derivative products, while the latter's product lines include antibodies and biomarkers, as well as an impressive number of products for proteomics and genomics, apoptosis assays, molecular biology reagents, and complementary assays products.
This partnership has enabled Vitro Biopharma to focus on the development of its own pipeline of drug discovery and development products including stem cell-based assays. Vitro Biopharma‘s innovative business model facilitates the establishment of diversified sources and well-implemented sales strategies to penetrate research and clinical development markets with its unique stem cell-based technology platform.
Each year, Frost & Sullivan presents this award to the company that demonstrates uniqueness in developing and leveraging new technologies, which significantly impacts both the functionality and the customer value of the new products and applications. The award lauds the high R&D spend toward innovation, its relevance to the industry and the positive impact on brand perception.
Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for outstanding achievement in areas such as leadership, technological innovation, customer service, and product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research.
About Vitro Biopharma
Vitro Diagnostics, Inc. dba Vitro Biopharma (vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells "Tools for Stem Cell and Drug Development™," including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships, including an alliance with Neuromics, Inc.. Neuromics, Inc. (neuromics.com) is a primary distributor of Vitro Biopharma products and a well-established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems. We jointly manufacture stem cell assay systems with HemoGenix®, Inc. (hemogenix.com), known as the MSCglo quantitative assay for determination of MSC quality, potency and response to toxic agents. Also, Vitro Biopharma's CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.
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Media Contact for Vitro Biopharma: Dr. Jim Musick
P: 303-999-2130 / F: 303-762-1240 - E: jim[.]vitrobiopharma.com.