NMDP BioTherapies
Helping deliver on the promise of cell and gene therapy
NMDP BioTherapiesSM is a non-profit organization created to save lives by making sure all people get the cell or gene therapy they need. Through industry-leading services, we help companies advance next-generation allogeneic cell therapies, so more patients can receive the best treatment for their disease.
Empowering the discovery, development and delivery of next-generation cell therapies
Since 2016, NMDP BioTherapies has provided dozens of organizations the resources to develop vital cell and gene therapies, including commercial-stage allogeneic companies.
To discuss our services, contact our team at biotleaders@nmdp.org.
Our services include:
Cell sourcing for cell and gene therapy
NMDP BioTherapies offers a world-class, proven infrastructure that delivers high-quality, compliant allogeneic cellular source material. In addition to providing the reliability and consistency required for cell and gene therapies, we help to source for therapy-specific donor attributes from an extensive donor registry.
Source material includes:
- Leukopaks: clinical-grade leukopaks, both non-mobilized and mobilized
- Patient-donor matched allogeneic material: human leukocyte antigen (HLA)-matched donated cells to treat specific patients
- Cord blood units: centralized, streamlined access to the domestic cord blood unit inventory in the United States
GMP leukopaks for cell therapy manufacturing
Our standard GMP leukopak is designed to be delivered quickly without sacrificing quality. Optional add-ons to the standard leukopak—including cryopreservation—offer flexibility to meet developer needs. This approach allows for ease in scale up as therapies advance into later clinical trial and commercial phases.
NMDP BioTherapies standard GMP leukopak
NMDP BioTherapies developed our clinical-grade leukopak offering with input from clinical- and commercial-phase cell and gene therapy companies. This means we are prepared to meet a variety of supply needs for cell therapy manufacturing. A drug master file is on file with the FDA for our standard offering to streamline regulatory filings for our partners.
In addition to the standard leukopak, we offer custom options to meet whatever needs our partners may have, including additional product testing and regulatory regions, and downstream cell processing (e.g., cell isolation).
Patient-donor matched allogeneic materials
Working with developers and clinical sites, we help to find materials for therapies that rely on a specific donor or cord blood unit that is matched to a specific patient at a one-to-one ratio.
NMDP BioTherapies leverages decades of experience working with transplant centers—along with cell and gene therapy expertise—to meet regulatory and developer needs. We also offer search strategy advice to clinical sites interested in consulting with us to select the best possible match that complies with therapy-specific requirements.
Leverage extensive networks
Our domestic transplant center network is wide, and includes many of the most renowned hospitals in the U.S. After years of established relationships with these centers, our protocols and systems—such as our donor and cord blood search applications—are part of their workflow for locating the best allogeneic match for their patients.
Additionally, we manage an apheresis center network to assist in high-quality collection. We provide apheresis center staff specific training for compliance with protocol requirements to ensure our partners receive materials that meet their needs.
Access a large selection of matched materials
We maintain a large, diverse donor registry and cord blood unit registry that provides a high likelihood of finding a match for patients while complying with any protocol requirements for donor attributes.
To discuss our services, contact our team at biotleaders@nmdp.org.
Options include:
Cord blood units for allogeneic cell therapy source material
Gain comprehensive visibility and streamlined access to the U.S. domestic cord blood unit (CBU) inventory.
Centralized access to cord blood units
Off-the-shelf CBUs are a rich source of cells for use in the development of allogeneic cell and gene therapies. However, CBUs with specific characteristics may be spread across multiple cord blood banks. Understanding which cord blood banks have the right CBUs, and qualifying and contracting with each one, takes time and resources.
We offer a central point to access fully characterized CBUs through our contracted NMDP BioTherapies Cord Blood Bank Alliance.
Access cryopreserved cord blood units with diverse specifications
Our NMDP RegistrySM contains extensive information about each CBU to allow for therapy-matched unit identification. Our experienced team uses our established logistics and supply chain management process to coordinate the safe transport and delivery of the valuable cryopreserved CBUs.
Specifications available for cord blood units include:
- Total nucleated cell (TNC) and CD34+ counts
- Viability and volume
- HLA and blood type
- Donor eligibility safety profile
- Unit age
- Licensure status
Outcomes data collection and analysis
Developing protocols and secure data storage systems for collecting, maintaining and analyzing outcomes data for patients post-therapeutic intervention is both time-consuming and costly, with no room for error.
Through CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a research collaboration between the Medical College of Wisconsin® and NMDPSM—we offer an extensive data infrastructure for patient outcomes data collection and analysis after cell therapy. We collaborate with the global scientific community to advance cell therapy worldwide to increase survival and enrich quality of life for patients.
Our outcomes registry facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, an extensive clinical outcomes database and a unique biospecimen repository.
Bioinformatics consulting for cell and gene therapy
Developing an allogeneic cell therapy means navigating a variety of challenges—such as building a cell bank to maximize target population coverage, determining the odds of finding donors that will match cell therapy criteria, or deciding whether it is possible to use HLA data that has significant gaps and ambiguities.
NMDP BioTherapies supports cell and gene therapy partners through multiple stages of therapy development. Our experts provide models, analyses and interpretations that offer answers to help our partners plan for cell therapy development and clinical trials.
A bioinformatics team uniquely qualified to support cell therapy needs
Our HLA and KIR work span decades. Our researchers and scientists advance the field of immunogenetics and hematopoietic cell transplant (HCT)/cell therapy genomics through the CIBMTR Bioinformatics Research Program.
That experience—along with nearly 40 years of patient outcomes data for HCT and cell therapies—allows us to develop methods that support proper donor/patient histocompatibility for allogeneic cellular therapies.
CIBMTR CRO Services for cell and gene therapy
Our clinical research organization (CRO) team has the expertise and experience to successfully lead cell therapy clinical trial execution.
A CRO team specialized in cell therapy
A company pioneering a new therapeutic modality needs a stable, trusted CRO partner that understands the unique needs of a cell therapy clinical trial. Equally important, it must be able to drive a clinical trial execution that is on schedule and within budget.
CIBMTR CRO Services set cell therapy clinical trials up for success and help mitigate risk. Our CRO team focuses only on cell therapy and HCT clinical trial design and execution, providing the specialized expertise cell and gene therapy developers need.
Contact NMDP BioTherapies
To discuss the services available through NMDP BioTherapies, contact our team at biotleaders@nmdp.org.