GMP Mobilized Leukopak
AllCells’ GMP Mobilized leukopaks are apheresis products collected from healthy donors treated with FDA-approved drugs to stimulate mobilization of CD34+ hematopoietic stem and progenitor cells from the bone marrow to the peripheral blood. This procedure results in large-scale yields of CD34+ cells. Peripheral blood is collected from IRB-consented donors using the continuous flow Spectra Optia® Apheresis System directly into ACD-A anticoagulant at AllCells’ FDA-registered, IRB-approved collection facilities. Regimen details: Reg H = Filgrastim (Neupogen®) 10ug/kg/day x 5 days + Plerixafor (Mozobil®) 240ug/kg/day x 2 days on day 4 and 5 (evenings), apheresis on day 5 and 6.
Donors with the right attributes are a critical part of any cell therapy program. AllCells Donor Management Services can help you find, screen and retain donors from our repository comprised of highly-characterized, HLA-typed donors with diverse demographics and clinical parameters that can meet program-specific criteria from research and development to commercialization.
GMP Mobilized Leukopak Products are enriched in CD34+, allowing for scalability and reproducibility. The product is quality controlled for viability using a validated AO/PI protocol and pass a Sterility Test in accordance with USP71 guidelines using compendial testing.
- Format: Fresh, 2 Paks
- Anti-coagulant: ACD-A
- Viability: NLT 90%
- Fill Volume: NLT 280mL
- Cell Concentration: FIO
- Sterility USP <71>: No growth
- Expiration: 4 days post collection
- Shipment at 2-8C with temperature logger