We do not compensate allogeneic donors. We support voluntary, unpaid donations for clinically and commercially consented cellular materials and products. This aligns with the policy of NMDP℠ and other international organizations. We believe the use of non-compensated donors promotes donor and patient safety.

In addition, it aligns with international requirements and accreditation standards. Many international regions strongly emphasize or require the use of voluntary, unpaid donors for cell therapies. Non-compensation allows for the broadest use of a client’s allogeneic therapy.

We have HLA information on all donors, as well as date of birth, self-identified race/ethnicity and donor sex assigned at birth. Additional characteristics, such as CMV status, may be available for subsets of the registry. Contact us to discuss your specific needs.

Having access to a large donor pool is important to help ensure availability and scalability in sourcing healthy donor starting material. This is true even for common donor characteristics.

The number of donor-specific attributes can have a significant impact on the needed donor pool size. The more donor attributes a therapy requires—such as viral positivity/negativity, specific HLA type, race or blood type—the larger the pool required.

As you add eligibility requirements, health authority and medical suitability requirements, study suitability requirements, and donor willingness to donate in the timeframe needed, your pool of potential donors can narrow significantly.

Yes. 94% of NMDP BioTherapies donors say they would go through the entire donation process again if asked. Leukopak donations are capped at 12 per year per donor unless an exception is granted by our medical team.

NMDP has successfully used a contracted network model for more than 35 years to collect donor cells for the facilitation of over 135,000 hematopoietic stem cell transplants under GMP conditions. By using this distributed partner model, NMDP BioTherapies can support a large volume of allogeneic donors in diverse geographic regions. This also allows us to align your collection requirements with the centers that have the required capabilities.

Allogeneic donor source material regulations are country dependent. As a baseline, we comply with U.S. FDA regulations for cellular source material, including 21 CFR Part 11 (GMP) and 21 CFR Part 1271 (GTP) and very often are asked to comply with European, Canadian and Australian regulations. Increasingly, we are receiving requests for expanded Asian regulatory compliance.

We will collaborate with you to develop protocols that will meet international regulatory requirements that will support your intended markets. Our quality and regulatory teams have supported collections complying with Health Canada, EMA and TGA regulations.

We work with each client to develop appropriate study-specific consent materials that will cover all intended uses, including pre-clinical research, clinical trials research and/or commercial use of the cellular source material.

We can discuss storage options with clients on a case-by-case basis.

Cord blood is a valuable starting material for allogeneic cell and gene therapies. Along with being readily available off-the-shelf, the cells are young so there is less chance for undesired mutations. Cord blood has demonstrated value for multiple therapies including NK cell isolation for CAR-NK therapies and induced pluripotent stem cell generation. This blog post shares non-biological factors cell and gene therapy developers should also consider: 4 benefits of cord blood for allogeneic cell therapies.

Licensed cord blood units meet donor eligibility and safety requirements for use in humans. They 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 biologically equivalent to and manufactured per laboratory procedures for licensed units, but were manufactured prior to licensure or are missing one or more of the specifications required in the BLA to support allogeneic transplant. These units may be eligible or ineligible, and must be released under IND if intended for use in humans.

Licensed cord blood units meet donor eligibility and safety requirements for use in humans. They 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. 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 byproducts of product processing may be available.

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.

Cord blood banks are independently owned and operated. There will be variations in manufacturing, practices and pricing. NMDP BioTherapies will standardize contracting, agreements, qualification, and distribution, and will control the variables as much as possible.

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.

We will work with you to develop a logistics plan that will fit your therapy’s needs. In general, we guarantee delivery in under 48 hours within the U.S. and under 72 hours internationally.

NMDP BioTherapies is not a courier company. Using a managed logistics model, we coordinate shipments with a variety of courier companies based on the shipping lane and your shipment type to optimize transport success.

Managed logistics involves coordinating with a variety of courier options, understanding their varying strengths, and adjusting utilization of these options based on the shipping lane and type of shipment. By taking this approach, we aim to optimize transport success.

NMDP BioTherapies is a subsidiary of NMDP℠, which has more than 35 years of experience managing the shipment of cellular therapies. This experience has shown us that it is important not to rely on a single courier. Each courier option will have their strengths and weaknesses, depending on the shipping lane.

Because we manage a large volume of shipments, we are well suited to determine the optimal couriers for a particular shipment.

We will recommend logistics partners depending on the shipment type and location. We have flexibility to work with a variety of shipping partners and/or shipping containers. We will work with you to develop the optimal solution for your therapy’s needs.

We have experience working with a wide variety of shipping materials. These will vary depending on the type of shipment. Some examples include:

• Cryoport dry shippers
• Credo Cubes
• Nanocoolers

All our shipments include a temperature monitor to track temperature through the life of the shipment. Additionally, we will work with you to ensure the optimal packaging is used to maintain the required temperature.

Yes, we have extensive experience transporting material across the globe.

We have a broad range of experience transporting material at a variety of temperatures. We can provide guidance on the packaging material and optimal shipping methods.

Yes. Our NMDP BioTherapies Collection Network team has extensive collection experience. They can work with you to develop your protocol-matched collection manual.

Yes. We have worked with a wide variety of apheresis centers and will advise you on centers that may have the capabilities needed for your collection protocol.

NMDP BioTherapies participates in several existing standards setting efforts. We work with a variety of stakeholders in the industry, including physicians, patients, apheresis centers, regulatory agencies and cell and gene therapy companies. This allows us to bring a unique perspective to these efforts. In addition, we bring the lessons learned in our 35+ years of experience facilitating hematopoietic stem cell transplants to emerging cell and gene therapy initiatives.

Yes. Our extensive team is experienced in apheresis collection for cellular starting material.

Prior to the first collection, develop key collection attributes that can be tracked with each collection. Our Collection Center Network team can work with you to develop appropriate KPIs to manage your collections.

Our team is most experienced in apheresis network management in the U.S. and Europe. We have some limited experience outside these regions. Please contact us to discuss your specific needs.