GMP Cryopreserved Clinical Leukopaks

Description

Clinical-Grade GMP Cryopreserved Leukopaks

CGT Global’s GMP Cryopreserved Leukopaks are collected under IRB-approved protocols from healthy, qualified donors at our FDA-registered and CLIA-certified Stem Cell Collection Centers. All collections follow strict Good Manufacturing Practice (GMP) guidelines to support clinical and translational research applications.

Using continuous-flow apheresis, we isolate peripheral blood mononuclear cells (PBMCs) into sterile, single-use collection bags containing ACD-A anticoagulant. Each Leukopak contains a rich population of lymphocytes and monocytes, with minimal contamination from granulocytes and red blood cells. Our facilities and processes are designed to support downstream cell therapy manufacturing and regulatory compliance.

Typical Cell Population Distribution (Pre-Cryopreservation)
Based on healthy donors. Individual donor variability applies.

• T cells: ~55%

• Monocytes: ~27%

• B cells: ~9%

• NK cells: ~8%

• CD34+ cells: ~0.1%

• Granulocytes: ~2.4%

Please note: Cell percentages are representative averages and are not guaranteed.

Cryopreservation Process
Immediately after collection and quality control, Leukopaks are cryopreserved in CryoStor™ CS10 (10% DMSO) using a validated controlled-rate freezing protocol to preserve cellular integrity and maximize post-thaw viability. Total nucleated cell (TNC) counts and viability are assessed prior to cryopreservation and documented as part of the batch record.

For best results, we strongly recommend using CGT Global’s validated Clinical Leukopak Thawing Protocol, available under our Technical Resources. Deviating from this protocol may reduce cell viability and functionality.

Shipping & Storage Recommendations
Cryopreserved GMP Leukopaks should be shipped in validated LN2 vapor-phase cryoshippers to maintain ultra-low temperatures during transit. Upon receipt, products should be either thawed for immediate use or stored in the vapor phase of liquid nitrogen (-150°C or colder).

Custom Clinical Collections
Need specific donor criteria or additional processing? Our team can support your clinical research with customizable GMP Leukopaks tailored to your protocol. Contact us to discuss donor matching, HLA typing, mobilized donors, or additional processing services.