LeukoCert™: GMP Healthy Leukopaks

Sanguine’s LeukoCert™ GMP-grade leukopaks contain billions of cells from a single donor. These leukopaks are available fresh, and in full- and half-packs from reserved donors for your project. Our community of healthy apheresis donors allows you to screen and identify the super donors who will fuel your cell therapy manufacturing.

Donor Reservation Process

Sanguine identifies donors

Sanguine establishes criteria to identify reserved donors, focusing on success and willingness for repeat apheresis collections, occurring as frequently as every 6 weeks.

You choose your donor(s)

Researchers or users screen multiple RUO Leukopaks from GMP-qualified donors to select the most suitable donor for their project.

Donor is Reserved

The selected donor is reserved for the specific project, ensuring they participate only in that project until completion.

GMP Leukopaks Collected

Leukopak collection from the reserved donor occurs at the cadence specified in the project plan.

Screening Considerations

Number of donors to screen

Sex assigned at birth Male Female

Race/Ethnicity African American/Black Asian/Pacific Islander Caucasian/White Hispanic/Latino Multiple races/ethnicities Native American

Age range:

Additional I/E criteria:

Quality and Testing

21 CFR Part 1271 Compliant Panel of infectious disease testing
HLA-typing targeted NGS HLA Class I/II
Certificate of analysis including ICCBBA IABT 128 compliant and statement of conformity to FDA Title 21 CFR Part 1271 standards