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…
Ensuring cell collection centers and cell therapy labs are meeting FDA regulatory requirements and providing high-quality starting material for your cell or gene therapy is critical to your therapy’s success. As the industry continues to rapidly advance, it is becoming more critical to integrate process efficiencies wherever possible. There is a solution: using an established…
The success of a cell therapy depends on the collection of high-quality starting material. But currently, a number of barriers are impacting the capacity of collection centers, which in turn, can create obstacles throughout the supply chain and delay delivery of cell therapies. Cell and gene therapy developers are required by the FDA to ensure…
Amy Hines, BSN, RN, oversees the Be The Match BioTherapies® Collection Network, which includes apheresis centers, marrow collection centers and cell therapy labs. She talked to us about some of the challenges the Network is facing, how Be The Match BioTherapies can help build efficiencies and how the organization plans to save more lives internationally.…
It’s no secret that cell and gene therapies are advancing at a rapid pace. As with any new innovations, unforeseen challenges are sure to accompany. One of the challenges generating buzz lately, is the need to define standards in the industry, specifically in the areas of apheresis collection and manufacturing. So, we’re going straight to…