nLiven PR™
GMP-ready pathogen reduced human platelet lysate.
As global regulatory expectations evolve, Sexton Biotechnologies is there to meet the challenge. With a validated pathogen reduction technology, nLiven PR established the gold standard for performance and quality of irradiated pooled human platelet lysate.
SPECIFICATIONS
DETAILS
- Validated pathogen reduction technology using E-Beam irradiation
- Available in 100, 500 ml
- Large donor pool lot sizes
- Manufactured from outdated FDA/AABB approved apheresis platelet units
- FDA master file, PMDA Certificate of Suitability
- Used for manufacturing in US, EU, and other clinical trials globally
- Manufactured under a certified ISO 9001:2015 Quality Management System
- Example CoA and IFU
- Culture supplement to replace FBS or AB Serum
- BioDefined composition reduces lot-to-lot variability
- Supports a wide range of cell types including MSCs, T-Cells, NK Cells, Endothelial cells, and more.
- Promotes improved in vitro and In vivo cell quality in CAR-T applications
- Typically used at 2%-10% concentrations.
- Used in 2D and 3D expansion systems
- Additional pathogen reduction applied per EU pharmacopeia