First of Its Kind Clinical-Grade Leukopak Now Facilitates Easier Regulatory Filing with Access to a DMF and Identification of Additional Characteristics Required to Qualify Cord Blood Units as Starting Material for Manufacture of Cell and Gene Therapies
MINNEAPOLIS– NMDP BioTherapies℠ formerly Be The Match BioTherapies, a leader in cell and gene therapy development support, unveiled substantial upgrades to its cellular starting material offerings, including incorporating a Drug Master File (DMF) with its rapid-delivery, standard GMP leukopak to simplify regulatory filings. The strategic enhancements to its suite are designed to address the evolving needs of the allogeneic cell therapy industry, emphasizing optimized delivery times, customizable options, and expanded capabilities.
“We have leveraged over three decades of experience in managing cellular product collections, working closely with cell and gene therapy developers to deliver an advanced allogeneic suite of compliant products,” said Tom Hochuli, President of NMDP BioTherapies. “These investments in our cellular starting material offerings are a testament to our commitment to advancing the cell and gene therapy industry. We are building products and services to meet the short and long-term needs of developers and continue to strive to supply industry-leading support and flexibility for allogeneic cell therapy development.”
NMDP BioTherapies supports organizations that are creating next-generation cell and gene therapies. With access to donors and cord blood units from the NMDP Registry℠, which is the world’s most diverse registry, and an extensive collection network, NMDP BioTherapies provides a wide variety of cell sourcing options for developers of allogeneic cell and gene therapies so that they can expand treatment options for patients with life-threatening or debilitating diseases.
“Along with our Cord Blood Bank Alliance members, we are addressing an important unmet need: identification of additional cord characteristics required to qualify units for manufacture of cell and gene therapies,” added Hochuli.
The updated product and service suite includes the clinical-grade leukopak , research use only (RUO) leukopak and cord blood units (CBUs), each tailored to support developers from early discovery through to commercialization. The suite includes:
- Optimized Standardized GMP Leukopak for Rapid Delivery with Optional Modular Customizations. NMDP BioTherapies has refined its standard GMP leukopak to offer a fresh, clinical-grade product that can be delivered quickly, complete with a DMF on file to facilitate regulatory processes. Developers can also benefit from modular customizations such as specific donor demographics, cryopreservation and international compliance, ensuring a match with their precise needs.
- Expanded RUO Leukopak for Versatile Research Applications. Recognizing the diverse stages of cell therapy development, NMDP BioTherapies has broadened its RUO leukopak capabilities. This expansion supports developers from initial phases, when specific donor characteristics might be unclear, to later stages when strict adherence to clinical requirements is a necessity.
- Enhanced CBU Offering for Allogeneic Cell Therapy. The Cord Blood Bank Alliance has also evolved its CBU offering, focusing on expanding testing capabilities for key characteristics, such as KIR and CD16. This advancement enables a more detailed analysis of the cord blood bank inventory, crucial for identifying units with characteristics vital for manufacturing allogeneic cell therapies. Partnering with NMDP BioTherapies provides access to a team of experienced regulatory and cell collection experts who have gained their expertise over 35+ years of managing global deliveries of cellular products for clinical and commercial use.
About NMDP BioTherapies
NMDP BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by NMDP’s industry-leading experience and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance the development of cell and gene therapies worldwide.
NMDP BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the NMDP Registry, the world’s most diverse registry of more than 7 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies. NMDP BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to successfully transport and deliver regulatory-compliant life-saving therapies across the globe. Through the CIBMTR, NMDP extends services beyond the cell therapy supply chain to include long-term follow-up tracking for FDA-approved CAR-T therapies.
To learn more about this rapidly evolving market, view the “Global Cord Blood & Tissue Banking Industry Report – Market Size, Segmentation, & Forecasts, 2024.”
