When you procure cellular starting material or distribute a cell or gene therapy product across international borders, you must consider the country or regional regulatory requirements at play and where they diverge. Allogeneic cell therapy sponsors face common challenges when treating a global patient population with therapies using healthy adult donor starting material.
Cord blood’s unique, naïve biology often comes up as a reason to use it as an allogeneic cell therapy source material. But as Cleveland Cord Blood Center Executive Director Marcie Finney explains, there are 4 non-biological factors cell and gene therapy developers should also consider.
Allogeneic cell therapy development has been top-of-mind in recent years as autologous cell therapies see continued success. For more than three decades, the largest group of HLA experts in the world has worked to create a unique cell source selection expertise. That expertise holds value for allogeneic cell and gene therapy developers, too.
The movement of fresh cellular starting material or a manufactured cell and gene therapy is a critical and time-sensitive piece of the supply chain ecosystem. At Be The Match BioTherapies®, these transports are coordinated and monitored by experienced logistics coordinators. In many cases, it’s our volunteer couriers who hand carry and deliver these products. “Our…
Umbilical cord blood is an abundant resource that is rich in cellular source material, which makes it an attractive option for cell and gene therapy developers. Get a better understanding of the benefits of using cord blood and considerations for contracting with multiple cord blood banks.
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.
The COVID-19 pandemic continued to disrupt lives across the globe in 2021, but that didn’t keep the cell and gene therapy industry from advancing. With many new regulatory approvals anticipated in 2022, the industry shows no signs of slowing down. We look back at 2021 and ahead to 2022 and beyond.
Cell and gene therapy developers are pursuing allogeneic approaches, which ideally could be produced in greater quantities and be available “off-the-shelf.” Those using natural killer (NK) cells and cells derived from induced pluripotent stem cells (iPSCs) are creating buzz in the industry. Drs. Sarah Cooley, Stephen Gottschalk and Stephan Grupp offer their insights.
The COVID-19 pandemic impacted nearly every aspect of the cell and gene therapy supply chain. That required companies throughout the cell and gene therapy industry to pivot quickly to continue to deliver for patients. Be The Match BioTherapies® was no exception.