The newly formed Be The Match BioTherapies Cord Blood Bank Alliance has the potential to open the door to new cell therapies by expanding awareness and enabling researchers and developers to more easily identify and access cord blood units for their work.
Many allogeneic cell therapy developers believe they can overcome HLA barriers. However, HLA is only one factor to consider, and the issue of histocompatibility should not be overlooked.
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.
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.
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.
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.