Produces 98% pure protein
THOUSAND OAKS, Calif., Feb. 24 /PRNewswire/ -- Bone Biologics, Inc. announced today that it's contract research and development organization, Aragen Bioscience, has completed development of a recombinant cell line and initial production process for UCB-1 (NELL-1) recombinant protein.
Bone Biologics has been developing the protein as a platform technology since 2004, leveraging the previous ten years of research in the lab performed by the founding scientists at UCLA. The mechanism of action is not only identified as to how it works, but why, through this exhaustive research effort. This platform technology is combined with DBX(R) demineralized bone matrix to promote bone growth in spinal fusion.
Aragen has produced UCB-1 (NELL-1) at a purity level Bone Biologics believes is sufficient for IDE submission. Results in animal trials using that protein have exhibited rapid bone growth, high quality of bone, and no ectopic bone growth. Efforts will now focus on scaling that process up to produce clinical grade product.
The platform technology will be subject to the FDA review and approval process, including clinical trials. It is not currently approved for use in humans.
Rick Srigley, CEO of Aragen Bioscience said, "This project has been exciting for us. UCB-1 (NELL-1) is a complex and challenging protein, but we believe that the cell line and process we have developed for Bone Biologics can be scaled up to provide protein at purity and productivity levels sufficient for Phase I clinical studies." William Jay Treat, Ph.D., President of Southwest BioProcessing Associates LLC, who has extensive experience in cell line development, scale-up optimization and commercial manufacturing provided key guidance during this process to Bone Biologics, said, "The professionalism, expertise, and awareness of keeping to a timeline by Aragen has developed a manufacturing process that is suitable to move to the next phase of UCB-1 (NELL-1) manufacturing.
About Aragen Biosciences
Aragen Biosciences, Inc. is a contract research and development organization in Morgan Hill, California. Aragen specializes in recombinant cell line and hybridoma development, cell culture and purification process development and production, cell-based assays and custom immunological services. (http://www.aragenbio.com/)
About Bone Biologics, Inc.
Bone Biologics is a convergence biotechnology company focused in the orthobiologics space. The company was founded in 2004 by the research scientists who had identified and validated the product in the lab over the previous ten years. This platform technology is the unique UCB-1 (NELL-1) protein formulated with tissue-specific scaffolds to only deliver the intended outcomes. The lead product effort is to promote bone growth in spinal fusion.
CONTACT: Bruce A. Hazuka of Bone Biologics, +1-818-324-2742
Web site: http://www.aragenbio.com//