NMDP BioTherapies Introduces Enhanced Cellular Materials for Allogeneic Cell Therapy Development

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…

International regulations for allogeneic cell source material

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.

Effect of rapid cell therapy growth on collection capacity

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.