Off-the-shelf cord blood units (CBUs) are a rich source of cells for use in the development of allogeneic cell and gene therapies. However, CBUs with the characteristics you need may be spread across multiple cord blood banks. Understanding which cord blood banks have the CBUs that meet your requirements is a challenge. And qualifying and contracting with each one takes time and resources.
Our Cord Blood Unit Sourcing service offers a central point to access fully characterized CBUs through our network of member cord blood banks.
We provide access to cryopreserved cord blood units for non-clinical, clinical and commercial use
We can help your company source CBUs for clinical trial and commercial use or non-clinical research use only (RUO).
|Clinical and commercial use||Non-clinical use|
|Licensed cord blood unit||Unlicensed cord blood unit||Research use only|
|Manufactured as a GMP-grade cellular product||Manufactured as a GMP-grade cellular product||Manufactured as a GMP-grade cellular product|
|Meets donor eligibility and safety requirements for use in humans||Meets donor eligibility and safety requirements for use in humans||Similarly manufactured and characterized, but does not meet eligibility and safety requirements for use in humans|
|Meets FDA licensure requirements for allogeneic transplant||Missing one or more specifications required in the BLA to support allogeneic transplant||Intended for:
· Validating, qualifying and investigating internal procedures and processes
· Engineering runs
|Must be released for licensed indication (currently HPC reconstitution) or under IND if off-label||Must be released under IND if intended for use in humans|
Blood-forming stem cells derived from cord blood are FDA-approved for use in patients who need hematopoietic stem cell transplantation (HSCT) for a disorder that impacts the hematopoietic system. Those that do not meet the specifications of the BLA or are to be used for another indication can be released under IND.
Our experienced team uses our established logistics and supply chain management process to coordinate the safe transport and delivery of the delicate cryopreserved CBUs.
Why choose cord blood for your allogeneic cell or gene therapy?
- Readily available off-the-shelf
- Young cells with less chance of undesired mutations
- Demonstrated value for multiple therapies including NK cell isolation for CAR-NK therapies and induced pluripotent stem cell generation
Our registry database contains extensive information about each CBU to allow for therapy-matched unit identification
The Be The Match Registry® lists more than 266,000 fully characterized cord blood units from our domestic member cord blood banks. When you work with Be The Match BioTherapies® you have access to the robust capabilities of our Bioinformatics team for cord blood bank inventory analysis.
Specifications available for cord blood units include:
- Total nucleated cell (TNC) count
- CD34+ count
- HLA type
- Blood type
- Donor eligibility safety profile
- Unit age
Looking for CBUs for allogeneic cell and gene therapy development?
Whether you need CBUs for clinical trial and commercial use or research use only, we can help you access cord blood units that meet your requirements. Our team is ready to connect to discuss your needs.
Our experience simplifies sourcing CBUs for your allogeneic cell therapy
With decades of experience qualifying and contracting with cord blood banks, our team has deep knowledge of banking practices and procedures. Since we have existing agreements with competent banks, you won’t need to spend time contracting and qualifying multiple suppliers.
We developed these relationships and experience through the National Marrow Donor Program® (NMDP)/Be The Match®. The Be The Match Registry lists a comprehensive profile of typing and cellular characteristics on eligible CBUs from our partner cord blood banks. Physicians search this robust database to find CBUs for patients who need HSCT.
Our member cord blood banks must meet rigorous participation requirements reviewed annually
Member cord blood bank participation requirements include:
- Accredited by AABB or NetCord-FACT
- Abide by NMDP/Be The Match Standards
- Meet NMDP/Be The Match Member Cord Blood Bank Participation Criteria
- Meet Quality System essentials such as Facility, Personnel, Administration and Support Services requirements
- Have at least 500 HPC(CB) units meeting NMDP/Be The Match Current Inventory Requirements for New Cord Blood Units
- Comply with WMDA Standards
Access additional services
Allogeneic Cell Sourcing
Provide a reliable source of healthy, screened adult donors and end-to-end support from donor identification to cell delivery.
Outcomes Data Collection and Analysis
Collect and examine long-term safety and efficacy data for commercialized cell and gene therapy products.
Consulting Services for Sponsors
Data and analytical expertise to help define your HLA targets and build your allogeneic cell bank.
Frequently asked questions
What is the difference between a licensed and unlicensed cord blood unit?
Licensed and unlicensed cord blood units both meet donor eligibility and safety requirements for use in humans. Those that are licensed meet FDA licensure requirements for allogeneic transplant and can be released for a licensed indication, which currently is HPC reconstitution. If off-label, a licensed unit must be released under IND.
Unlicensed cord blood units are missing one or more of the specifications required in the BLA to support allogeneic transplant. These units must be released under IND if intended for use in humans.
What other material may be available on CBUs?
A limited number of integral segments are attached to the CBU. Reserve samples that represent maternal serum/plasma as well as residual cord blood RBCs, plasma, and DNA that are byproduct of product processing may be available.
What is required for a CBU to be released from a bank?
Cord blood banks will perform confirmatory HLA typing to verify identity. They will also perform release tests to assess the quality of the CBU before distribution. Each bank has their own process and menu of tests.
Can I expect that the process will be the same across all domestic member banks?
Cord blood banks are independently owned and operated. There will be variations in manufacturing, practices and pricing. Be The Match BioTherapies will standardize contracting, agreements, qualification, and distribution, and will control the variables as much as possible.
Why might CBUs lack some of the testing required for finished pharmaceuticals?
Cord blood has traditionally been manufactured for hematopoietic reconstitution under FDA Good Tissue and Good Manufacturing Practice. Manufacturing is considered minimal manipulation which makes irrelevant some of the testing required for pharmaceuticals that may be extensively manufactured.
Interested in cord blood as a source material?
Our team has unparalleled experience and relationships with cord blood banks across the U.S. Let’s start the conversation.