Cryopreserved Leukopaks GMP
Cryopreserved Leukopaks from the Red Cross are meticulously prepared using validated manufacturing methods, ensuring high standards for clinical applications. Processed in a GMP-compliant cleanroom at our Manufacturing Science and Technology (MSAT) Lab in Philadelphia, PA, these leukopaks offer reliability and effectiveness for your clinical research and therapeutic development needs.
Key Features
- Cryopreservation: Our 5% DMSO cryopreserved leukopak utilizes a validated process with CryoStor®, performed within our GMP-compliant cleanroom, to ensure optimal cell cryopreservation and viability.
- 2x Total Blood Volume to be processed, volumes available include Tenth (30mL) and Quarter (70mL) total product volume.
*Concurrent plasma upon request.
* Real-time blood characterization of lymphocytes T, B, M, and NK within 30 minutes post-collection, including an assay report available in limited geographies.
- GMP-Compliant Processing: All processing occurs in a GMP-compliant cleanroom, adhering to strict standards to maintain product quality for clinical use.
- Proven Stability: Product stability studies confirm the reliability of cryopreservation and the effectiveness of cell thawing for clinical applications.
- Custom Donor Selection: HLA typing, KIR typing, and additional specialized infectious disease testing are available upon request to meet specific client requirements.
- Diverse Donor Pool: Donors are sourced from our extensive network, offering a wide range of backgrounds to meet diverse research needs.
- Comprehensive Quality Assurance: All GMP products undergo sterility, endotoxin, and mycoplasma testing, conforming to 21 CFR Parts 210, 211, and 1271 standards.
- Documentation Available: Certificate of Conformance and Analysis are available upon request to provide assurance of product quality.
We are committed to supporting your clinical research and therapeutic development with high-quality, compliant cryopreserved leukopaks.