Clinically Screened Fresh Healthy GMP Leukopak for Cell Therapy and Process Development

Healthy GMP Leukopak is collected via leukapheresis from healthy, IRB-consented adult donors under strict current Good Manufacturing Practices (cGMP). Each leukopak contains a high concentration of mononuclear cells, including T cells, B cells, NK cells, and monocytes, and serves as an essential starting material for translational research, process development, and cell therapy manufacturing.

Product Features

• Research Use Only (RUO) or GMP-grade leukopaks available
• Collected under cGMP-compliant protocols
• High yield of viable PBMCs
• Donors undergo full clinical screening and viral testing
• Shipped fresh in validated conditions
• Customizable volumes and donor criteria upon request

Donor Metadata

• Healthy, IRB-consented adult donors
• Demographics: age, sex assigned at birth, race/ethnicity
• Complete clinical and serological screening available

Applications

• Cell therapy process development and optimization
• Immunophenotyping and T/NK cell expansion
• CAR-T, CAR-NK, and engineered cell therapies
• GMP assay development and quality control testing

Compliance and Quality Assurance

• Collected at FDA-registered, cGMP-compliant facilities
• IRB-approved informed consent with 21 CFR Part 11 compliance
• Donor data and handling fully HIPAA-compliant

Ordering & Customization

Healthy GMP Leukopak is available fresh or cryopreserved. Custom donor selection, cell counts, or documentation requests may be directed to [email protected].