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.
- 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- Manufactured from outdated FDA/AABB approved apheresis platelet units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
nLiven PR contains a pathogen-reduction step in the manufacturing process to minimize the residual risk of pathogens/viruses contained in the final product.
nLiven PR is pathogen reduced by electron-beam irradiation.
Yes, viral inactivation studies have been completed.
Sexton has data supporting performance up to at least 17 months from date of manufacture at -20C storage
Yes. nLiven PR is used in multiple clinical studies across the globe.
Ex vivo expansion of cells such as MSCs, ASCs, T Cells, etc. Please connect with us to learn which Sexton hPL is right for your application.
Yes. We are ISO9001:2015 certified.
How can we help you?
Get in touch
BioLife Solutions Inc.
3303 Monte Villa Parkway,
Suite 310, Bothell , WA 98021 USA
For assistance, please call us Monday
through Friday (9:00 am to 5:00 pm PST) at:
Toll Free (North America): +1.866.424.6543