This piece was originally published in November 2019 on CellandGene.com We are living through one of the most exciting eras biopharmaceutical science has ever seen. Following the first U.S. and European regulatory approvals of gene therapies and CAR-T therapies in recent years, activity in this industry has skyrocketed. In the U.S., more than 800 clinical…
Challenge When patients’ lives rely on a manufactured cell or gene therapy arriving exactly when and where it needs to, it is essential to ensure each step of the critical supply chain is managed as efficiently as possible. Cellular starting material collection is at the beginning of that supply chain, making cell collection processes vital…
One patient, one product. The successful on-time delivery of cell and gene therapies isn’t just good business—it’s a matter of survival for patients. When there’s no room for mistakes, an advanced approach is needed to overcome supply chain disruptions that create barriers to successful on-time delivery. Severe weather, customs complexities and flight delays are three…
Coordinating the collection and delivery of cells for cell and gene therapy developers begins long before the first patient or donor is collected. Our Be The Match BioTherapies® Collection Network Liaison team works with cell and gene therapy clients to understand their needs. Then, they use established, standardized approaches to onboard, audit and train the…
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…
For cell and gene therapy companies developing allogeneic therapies, including allogeneic CAR-T or T-cell immunotherapies, getting high-quality starting material from healthy adult donors is critical to the success of their therapies. But, what is it like to be the allogeneic donors who get the call asking them to be volunteer donors? And why would they…
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…