Leukopaks
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
Versiti Leukopaks are now available for both Research Use Only and Clinical Grade applications.
Contact us to learn more.
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.
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.
~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.
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.