Cell therapy companies large and small face challenges in securing the raw materials they need for their research and therapy production. That was the message delivered by industry veteran Amy Hines, director of Collection Network Management, Be The Match BioTherapies, at this year’s Cell & Gene Therapy World, hosted by Phacilitate last month in Miami.…
In November, the FDA released its long-awaited regenerative medicine policy framework consisting of four guidance documents; two final and two draft. The guidance documents arrive at a time of rapid growth and expansion in the commercialization of regenerative medicines and represent the FDA’s attempt to ensure safety and effectiveness of the therapies, while spurring innovation…
One of the biggest hurdles in commercializing cell therapies is not the regulatory process, nor is it marketing a brand new, first-in-class product. Instead, many feel that the biggest challenge facing companies developing cell and gene therapies is proving to be the manufacturing process. Manufacturing CAR-T therapies presents multiple unique challenges. First, developing a personalized…
For years, umbilical cord blood (UCB) transplant was considered an acceptable alternative unrelated donor graft for the treatment of leukemia including reconstituting a patient’s immune system. Typically UCB transplants could be performed without the worry of precise patient-donor HLA-compatibility. To date, more than 35,000 cord blood transplants have been conducted worldwide. As use of the…
Since its debut in 2012, CRISPR-based gene editing has taken the scientific world by storm. From disease modeling to prenatal screening, the innovative platform has been hyped and hailed as the ultimate scientific multi-tool—capable of revolutionizing the treatment of human disease. In the flood of headlines and hyperbole, it can often be hard to determine…
One of the core components of our MatchSourceSM technology platform is a powerful, predictive search algorithm we call HapLogicSM. We sat down with Katie Howe, Ph.D., manager, Immunogenetic Operations and Research, and Caleb Kennedy, Ph.D., senior manager, Bioinformatics Research, to learn more about HapLogic and the important role search algorithms play in allogeneic drug development.