nLiven PR™

N-Liven PR product shot

Evaluate HPL

Media that empowers your cells

nLiven PR™ is a human platelet lysate (hPL) manufactured using a unique pathogen reduction process that reduces risks and improves downstream cell performance.

Performance

  • Proprietary E-Beam irradiation process
  • Improves expansion of cells compared with supplements such as FBS and Chemically Defined media
  • Highly consistent across lots allowing for reproducible manufacturing of cell product
  • Performance in both 2D and 3D culture systems;

Quality

  • Manufactured under a certified ISO9001:2015 Quality Management System
  • Certificate of Analysis Documenting testing for Sterility, Endotoxin, Mycoplasma
  • BM-MSC growth verification assay for Clinical Grade product
  • Certificates of Origin and Compliance available
  • Sexton Biotechnologies supports regulatory filings and audits of the process or facility

Regulatory

  • U.S. FDA DMF, PMDA regenerative medicine eligible, approval in EU clinical studies
  • Manufactured from expired apheresis platelet units sourced from AABB-accredited and FDA-registered blood centres
  • Raw materials meet FDA and AABB requirements for platelet transfusion
  • Full donor traceability
  • TSE Statements, COC and Non-animal component statements available