Leukopaks

Leukopaks

Human Leukopaks for Research

Versiti’s peripheral blood mononuclear cell (PBMC) product is an enriched, fresh leukapheresis product composed of high concentrations of monocytes and lymphocytes, but may also contain lower concentrations of platelets, plasma and red cells. Specific product characterization available upon request to meet unique study needs

The Leukopak Gap

With significant growth in the cellular therapy market projected over the next 4-6 years, several limiting factors, including the high cost of leukapheresis and stringent donor recruitment criteria for leukopak collections pose a unique set of challenges for companies without significant experience in the space.

Product Specifications

Leukopaks are sourced from individual donors under an IRB-approved protocol. Products are collected by leukapheresis where white blood cells are concentrated and shipped fresh to your facility. Leukopak products are available with or without G-CSF mobilization to meet your specific cellular therapy or research needs.

Product Criteria

LeukoPaks® are collected at Versiti's FDA-registered collection center from IRB-consented healthy human donors by leukapheresis CMNC collection protocol in ACD-A anticoagulant.

~10-15B TNC

Product TNC yield may vary, depending on individual contributors.

~8-12 Liters

Standard operating procedure is two blood volumes from a healthy contributor.

CMV Antibody, Hepatitus B Surface Antigen, Hepatitus C Core Antibody, Hepatitis C Virus Antibody, HIV Antibody, Human T-Lymphotropic Virus, Trypanasoma cruzi Antibody (Chagas), West Nile Virus (WNV).

Quality Assurance

PBMC products are collected in Versiti’s FDA-registered collection centers following SOPs and formal quality systems that result in reduced variability and risk. PBMCs are collected from a single IRB-consented contributor by leukapheresis using the Spectra Optia Apheresis System continuous mononuclear cell (CMNC) collection procedure. Contributor eligibility is established prior to PBMC collection. Each product receives a Certificate of Analysis (COA).

Leukopak Characterization and Customization

A general health assessment, testing for infectious disease and additional characterization tests are performed to determine eligibility. All of Versiti’s Leukopak products receive High-Resolution HLA by NGS Characterization, ABO typing, and infectious disease testing, including CMV, Hepatitis C, Hepatitis B, HIV, and West Nile Virus. Additional infectious disease testing or characterized Leukopaks may be available upon request to meet specific study requirements.

Non-Transfusable Products for Research
As a blood center, Versiti is committed to stewardship of the precious gift that our donors provide. We make products that have expired or are found to be unsuitable for transfusion available to help advance new frontiers in science and medicine.
Prospective Blood Product Collections
Versiti’s expertise in blood collection, apheresis procedures, and donor management ensures procurement of the highest quality human blood products required to support your unique research study needs.
Human Blood Products for Research
Versiti Clinical Trials can provide our partners with blood products for use in clinical trials and research studies, as needed.