Cryopreserved Mobilized Leukopaks (RUO+)

Product Description: Cryopreserved Mobilized leukopaks are custom order apheresis products collected from healthy donors treated with G-CSF to stimulate mobilization of CD34+ hematopoietic stem and progenitor cells from the bone marrow to the peripheral blood. Peripheral blood is collected from IRB-consented donors using the Spectra Optia® Apheresis System.

Mobilized leukopaks are processed in our Center for Cell and Gene Therapy by using an automated and enclosed system. Post processing, the cell product is assessed for the expression of CD45/CD34 and viability using flow cytometry. The mobilized leukopak products are enriched in Hematopoietic Stem Cells (HSCs), thus representing an ideal source for the isolation CD34+ cells.

Size: 2.5B and 5B

Cryopreservation and Storage: Cell products are cryopreserved in CryoStor CS10 using a controlled rate freezer. Cryopreserved products are stored in LN2 tanks and shipped in cryo dewars.

Thawing Instructions: Refer to our thawing protocol

*If you are interested in ordering this product, kindly fill out the form below and a Gift of Life Biologics representitive will contact you within 2 business days.

**GMP/GTP Mobilized Cyropreserved Leukopaks COMING SOON. Management expects the Gift of Life ISO-7 clean room suites to be operational in H2 2024 at which point we will be able to provide this product offering.

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GTP-Compliant

GTP-compliant products are collected in an FDA-registered collection center at the Gift of Life vertically integrated facility in South Florida from IRB consented healthy human donors using the Spectra Optia® Apheresis System. To guarantee reduced variability and risk, Gift of Life has implemented standard operating procedures and formal quality systems as part of our GTP-compliant qualification. All collections are performed in accordance with FDA 21 CFR part 1271 for human cells, tissues, and cellular tissue-based products.

GTP-compliant products are eligible for use in research & development, clinical and commercial settings and applications in the US, EU and Canada.

RUO+

RUO+ is Gift of Life Biologics’ research grade material offering. So, what is the plus (+)?

The RUO+ offering is the highest quality research grade material on the market. The RUO+ products are produced in a GTP facility and offer customers an introductory priced product ideal for companies conducting researchor process validation. The RUO+ products include infectious disease marker testing, next generation human leukocyte antigen (HLA) testing, product purity, potency testing and more.

RUO+ products are eligible for use in research & development settings and process validation.