Evaluate HPL

INCREASE THE POTENTIAL OF YOUR CAR T-CELLS

T-Liven PR™ is a T-Cell validated pooled Human Platelet Lysate (hPL) shown to generate high potential CAR-T Cells.* for treatment and cart therapy.

This product is released against a T-cell growth clonal expansion performance assay and supports manufacture of CAR-T cells. T-Liven PR is offered in bag format and in customizable volumes. Available as 100ml off-the-shelf bag, T-Liven PR can also be filled to meet user volume specifications, negating the need to aliquot in house. Multiple packaging options, including bag size and input/outlet tubing, can also be selected to best meet processing needs for CAR T therapy.

Performance

• Proprietary E-Beam irradiation process
• Increased expansion of CAR T Cells
• Increased percentages of naïve and central memory CAR T Cell phenotypes compared with AB Serum or FBS
• Highly consistent across lots allowing for reproducible manufacturing of cell products
• Performance in both 2D and 3D culture systems
• Improved transduction efficiency compared with AB Serum

Quality

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

Regulatory

• U.S. FDA DMF, meets PMDA and EU expectations for use in clinical manufacturing 
• 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