Use of Ultra‐Low Attachment Flasks Aids Manufacturing of the Macrophage‐Like Cell Therapy Product DUOC‐01 but Changes Product Phenotype

摘要

DUOC-01 cells are a macrophage-like cell therapy product derivedfrom umbilical cord blood that is currently being evaluated in aphase I clinical trial for patients with congenital lysosomal storagediseases (ClinicalTrials.gov Identifier: NCT02254863.) Manufacturingof DUOC-01 involves isolation of mononuclear cells from previouslycryopreserved cord blood, plating on tissue culture flasks,and culturing for 21 days. Because of the strong adherent propertiesof these cells, scraping in addition to trypsinization is requiredduring harvest, which decreases cell viability and is difficult to performin a GMP environment.