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, April 16, 2024 — NMDP BioTherapiesSM (formerly known as the Be The Match BioTherapies), a leader in cell…
Race, ethnicity and ancestry. How are they different? And, as testing and cell therapy science evolves, do they still impact HLA genotyping? That was the focus of discussion
The newly formed NMDP BioTherapies Cord Blood Bank Alliance has the potential to open the door to new cell therapies by expanding awareness and enabling researchers and developers to more easily identify and access cord blood units for their work.
Many allogeneic cell therapy developers believe they can overcome HLA barriers. However, HLA is only one factor to consider, and the issue of histocompatibility should not be overlooked.
When you procure cellular starting material or distribute a cell or gene therapy product across international borders, you must consider the country or regional regulatory requirements at play and where they diverge. Allogeneic cell therapy sponsors face common challenges when treating a global patient population with therapies using healthy adult donor starting material.
Cord blood’s unique, naïve biology often comes up as a reason to use it as an allogeneic cell therapy source material. But as Cleveland Cord Blood Center Executive Director Marcie Finney explains, there are 4 non-biological factors cell and gene therapy developers should also consider.
Allogeneic cell therapy development has been top-of-mind in recent years as autologous cell therapies see continued success. For more than three decades, the largest group of HLA experts in the world has worked to create a unique cell source selection expertise. That expertise holds value for allogeneic cell and gene therapy developers, too.
The movement of fresh cellular starting material or a manufactured cell and gene therapy is a critical and time-sensitive piece of the supply chain ecosystem. At Be The Match BioTherapies®, these transports are coordinated and monitored by experienced logistics coordinators. In many cases, it’s our volunteer couriers who hand carry and deliver these products. “Our…
The rapid growth of the cell and gene therapy industry is a positive for patients. However, it comes with increasing demand for high-quality cellular source material collected at apheresis centers. Managing collection capacity impacts from this growth requires understanding challenges from the perspective of the apheresis center and collaboration across the industry to develop solutions.