Collection: LeukoPAC™ Apheresis-Derived Products

Utilizing apheresis materials is simplified with OrganaBio’s LeukoPAC™ portfolio of products, which includes RUO and GMP grades, fresh and frozen leukopaks, and isolated cells. PBMCs, T cells, and NK cells are among the subsets of isolated cells, with custom isolations available upon request.

From screening to production and release, each part of our process is done with quality at the forefront. beginning with a stringent 3-part donor screening process, including administration of a comprehensive, AABB and FDA approved Donor History Questionnaire. All donations are made through HemaCenter, a wholly owned subsidiary of OrganaBio, which is an FDA registered apheresis center accessible solely by OrganaBio customers.

OrganaBio’s donor pool, collection SOPs, and processing methods are consistent across RUO and GMP formats for a seamless transition into clinical manufacturing:

• Each full leukopak has a minimum of 10 billion cells from a single donor
• PBMC recovery from leukopaks is consistently ≥ 70%, and leukopaks contain ~18% NK cells and ~60% T cells, on average
• Coupled with unparalleled characterization for the product as well as the donor, the data package for the donor includes demographics, biometrics, smoking status, infectious disease serology and markers, immunophenotyping and high-resolution HLA data, and are further characterized by TNC, viability, and CBC.
• No hidden upcharges for additional meaningful data on the products.