Gift of Life Biologics’ made-to-order fresh leukopaks are created based on specific customer needs and can be provided as either research grade (RUO+) or GTP/GMP compliant material.
Fresh products are collected in Gift of Life’s owned and operated AABB accredited apheresis center using the Terumo Optia CMNC protocol.
Gift of Life operates a large and diverse registry of over 465,000 highly characterized donors.
As a World Marrow Donor Association accredited stem cell donor registry, Gift of Life has been providing products for transplant for three decades, and starting material for further manufacture meets the same rigorous quality standards.
*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
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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.