Allogeneic cell therapy development can pose logistical challenges. Developers and researchers that rely on adult donors for cellular starting material may encounter barriers such as donor availability, collection slot availability, or even a change in a donor’s health status. However, there is a rich source of cellular starting material that doesn’t have those challenges: umbilical cord blood.
Cord blood units (CBUs) are cryopreserved and available off-the-shelf, highly characterized, and available for research, clinical, or commercial use. In addition, CBUs are in abundant supply. The donor availability or eligibility issues that a cell therapy developer may experience with an adult donor do not exist with cord blood.
Yet, cord blood is not without logistical challenges even with these advantages. The CBUs a developer or researcher needs may be spread across multiple cord blood banks. In addition, getting CBUs from a bank to a manufacturer or lab requires care and expertise.
However, logistical solutions exist for cell therapy developers and researchers that want to take advantage of the benefits cord blood offers.
Cord blood banks
Two options exist for cell therapy developers or researchers that need access to CBUs from multiple cord blood banks: either qualify and contract with each individual bank or work with a cord blood unit sourcing service to streamline this process.
For example, Be The Match BioTherapies offers a single point of access to multiple cord blood banks as part of the National Marrow Donor Program/Be The Match, and has agreements with a subset of its 16-member cord blood banks. These banks manufacture and store the more than 266,000 CBUs listed on the Be The Match Registry.
The member cord blood banks have gone through a supplier qualification process that takes approximately one year. These banks must continue to meet rigorous participation requirements that are reviewed annually.
In addition, many of the cord blood banks have experience that is advantageous to cell therapy developers. The blood-forming stem cells derived from cord blood are FDA-approved for use in patients who need unrelated hematopoietic stem cell transplant for a disorder that affects the hematopoietic system.
While the indication is different, cord blood banks understand the regulatory requirements for an FDA-approved product and have experience manufacturing GMP-grade products that comply with the FDA licensure requirements.
This single point of access to qualified cord blood banks centralizes the supplier qualification process for both cell therapy developers and cord blood banks. It also adds efficiencies by tapping into established processes.
CBU inventory
One of cord blood’s unique qualities is the ability to highly characterize it after collection and prior to listing for use. A cell therapy developer or researcher will have access to specifications—such as total nucleated cell count, CD34+ count, HLA type, donor eligibility safety profile, volume, and viability—that can help with the selection of CBUs that fit specific therapy requirements.
However, understanding which cord blood banks have the CBUs that meet those requirements can be a logistical challenge. This is another area where our cord blood unit sourcing service adds efficiency for cell therapy developers and researchers.
Through these services, developers and researchers gain comprehensive visibility into the domestic cord blood unit inventory. Bioinformatics experts support developers and researchers in analyzing the cord blood bank inventory in member databases to locate the best CBUs for their specific needs, whether for clinical or commercial development.
The support, however, extends beyond identifying the CBUs and the cord blood banks where the units are located. CBU sourcing services also often oversee the safe transport and delivery from the cord blood bank to the CBU’s final destination.
Safe transport of CBUs
The off-the-shelf, cryopreserved nature of cord blood units means some of the logistical challenges that surround adult donors do not exist. But that does not mean the logistics around moving CBUs from point A to point B should be taken lightly.
Cryopreservation at such a low temperature requires proper handling to avoid risks to the integrity of the product container. Additionally, dry shippers used to transport cryopreserved CBUs must be managed properly to prevent temperature fluctuations and maintain the product in an uncompromised state before its arrival.
While a dry shipper can hold a charge for approximately eight days, a cell therapy developer can’t risk the product getting lost in transit.
This is where an experienced cord blood unit sourcing service is also crucial. If a problem arises, the team knows how to troubleshoot to allow for a safe, on-time product delivery.
That is why working with a logistics team that has decades of experience working with cord blood banks and shipping companies to coordinate and oversee the safe, time-sensitive transport of CBUs is invaluable.
Cord blood is rich in naïve cellular material, and its abundantly available supply make it an attractive resource for cell therapy research and development. To truly take advantage of all that cord blood has to offer, cell therapy developers and researchers must keep its unique logistical considerations in mind and partner with organizations that have the experience to deliver.
Donna Regan is the Director of Customer-Ready Products for the National Marrow Donor Program/Be The Match, including Be The Match BioTherapies.