Autologous and allogeneic CAR-T therapies continue to hold significant promise for patients. But with that potential comes challenges, as more CAR-T therapies enter clinical trials and commercialization. Some are universal to both autologous CAR-T and allogeneic CAR-T, but each has its unique obstacles, too. Abby McDonald, PhD, supervises the Solutions Development team for Be The…
What if you could shorten the time it takes to activate apheresis and cell collection sites to begin collecting starting material for your cell or gene therapy and simultaneously create efficiencies for those sites? A standardized quality system audit (QSA) program, like the Quality System Audit Program (QSAP) offered by Be The Match BioTherapies®, helps…
This is no doubt an exciting time in the cell and gene therapy field. Hundreds of cell and gene therapy products are currently in clinical trials. And earlier this year, former FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, predicted the FDA will approve 10 to…
The UCLA Health Hematologic Malignancy/Stem Cell Transplant Program has been a pioneer in providing cell therapies to patients with hematologic cancers and disorders. In 2015, UCLA began participating in multisite clinical trials for CAR-T therapy and was one of the first centers in the nation to offer both FDA-approved CAR-T therapies, Kymriah® and Yescarta®. As…
A well-designed cell and gene therapy supply chain is critical to patient care. Managing the cell therapy supply chain is a mission-critical industry skill. Yet, no matter how well designed your supply chain is, human-based therapies are subject to variability at each stage of delivery. At Be The Match BioTherapies®, we make sure our team…
The rapid increase of emerging cell and gene therapies is putting stress on the infrastructure that supports the collection and processing of cellular starting material. Industry standardization can help ease this strain. While there are many opportunities for standardization in cell collection and processing, one that could have an immediate impact is a quality system…
In August, Petr Machalik, M.S., joined Be The Match BioTherapies® to support the organization’s international expansion. We spoke to him about key challenges facing cell and gene therapy companies in the EU and how Be The Match BioTherapies is poised to support them. After spending a number of years as the lead apheresis network manager…
Last month, the FDA issued six draft guidance documents specific to gene therapy development as their latest effort to update regulatory framework in the cell and gene therapy sector. This follows the release of a series of guidances and draft guidances in late 2017 also aimed at sponsors in this space. This most recent release…
2018 has been a year of advancement for the cell therapy industry. With the first two approved CAR-T cell therapies now on the market, organizations are shifting their focus from commercialization to industrialization through well-designed supply chains, standardized quality assurance practices and long-term outcomes tracking to support current and future cell therapy products. Let’s take…