The rapid growth of the cell and gene therapy industry is a positive for patients. However, it comes with increasing demand for high-quality cellular source material collected at apheresis centers. Managing collection capacity impacts from this growth requires understanding challenges from the perspective of the apheresis center and collaboration across the industry to develop solutions.
As a cell and gene therapy developer, your cell collection protocol requirements and specifications will impact your apheresis center network selection strategy and your ability to efficiently scale your processes. Any time your protocols or processes differ from those in place at a center, there are likely implications for training, forms and standard operating procedures (SOPs), which can delay your first collection.
Looking back at the headlines in advancements in cell and gene therapy in 2019, one theme that comes to mind is collaboration. New partnerships have encouraged progress in the field. One example is the recently announced alliance between Harvard and MIT to develop a Center for Advanced Biological Innovation and Manufacturing. And cooperation between stakeholder…
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…
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…
Chimeric antigen receptor (CAR) T cell therapies and other new immune effector cell therapies are offering hope for many patients with relapsed and refractory leukemia, lymphoma and other blood cancers. However, these therapies also have known serious side effects, including cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS). Because the definitions and…