Gift of Life Biologics

Top quality, rigorous standards

Starting material is collected in Gift of Life’s owned and operated AABB accredited apheresis center using the Terumo Optia CMNC protocol. Testing is performed in Gift of Life’s owned and operated CLIA-compliant high complexity testing laboratory. 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. Products can be supplied fresh or cryopreserved in our in-house cellular therapy laboratory. Donors are screened and collected and products are processed in accordance with GMP and GTP, adhering to 21 CFR Part 1271. We invite requests with custom requirements to meet your needs.

Current product offering from vertically integrated facility

Leukopaks
(Fresh and Frozen)

Peripheral Blood Leukopak (non-mobilized)
G-CSF Mobilized Peripheral Blood
Dual mobilized (G-CSF and Plerixafor)

Product Grade:

GMP/GPT FDA Compliant (EMA and other regulatory agency requirements can be met upon request)
RUO+ : Our research use only plus (RUO+) product is manufactured in a highly similar manner to GMP/GTP process at a lower cost for efficient transition from research to clinical use

BioBank
(Frozen Vials)

Peripheral Blood Mononuclear Cells
CD34+ from mobilized peripheral blood
CD4+ Helper T Cells
CD4+ CD8+ (CD3+) T Cells

Custom Orders

Offering a Single Source Solution to meet your custom needs:

Donor registry of > 446,000 well characterized allogeneic donors
National donor recruitment / management team
Unique apheresis collection center
CLIA testing laboratory
Cellular therapy, processing, isolation, and cryopreservation laboratory
Quality systems and regulatory compliance office
Shipping and logistics

All cells are collected and processed at our on-site apheresis center and processed at our cell therapy laboratory with healthy IRB consented donors.

Custom Services

Customer service is our top priority and we specialize in custom solutions. We frequently work with cell and gene therapy developers to meet specialized donor selection, collection, testing and processing needs. Because resources and team members are in-house, we turn around projects quickly and efficiently. Please contact us!