ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted human platelet lysate manufactured under cGMP and suited for cell-based research and cell therapy applications. ELAREM™ Ultimate-FDi is gamma-irradiated which provides a high penetration depth of ionizing radiation and is effective against a wide range of viruses. Gamma-irradiation and viral panel testing is performed according to ICH and EMA guidelines (ICH Q5A (R1) and CPMP/BWP/268/95).
- Developed for clinical and therapeutic applications.
- Xeno-free cell culture supplement supports rapid cell expansion.
- A growth factor rich, heparin-free supplement that is a superior alternative to FBS.
Due to the fibrinogen-depletion process, ELAREM™ Ultimate-FDi does not require an anticoagulant addition. Each batch is produced from large pools of platelet units and is manufactured from healthy blood donors obtained from licensed blood centers in the US.
|Intended use||Media supplement, cell culture, cell therapy research, drug discovery, MSCs, T Cells, Hematopoietic Stem Cells, and iPSCs|
|Endotoxin||< 10.0 EU/mL|
|Shelf-Life||18 months from date of manufacture|
|Storage||Store at -20°C|
|Total Protein||4.0 - 8.0 g/dL|
|Source||US donors, AABB-accredited and FDA-registered blood banks|
|Viral Testing||Final product is gamma-irradiated in order to comply with the highest safety guidelines for clinical applications. Virus panel testing is performed according to ICH and EMA guidelines (ICH Q5A (R1) and CPMP/BWP/268/95).|
|Biological Testing||Tested and released in compliance with the relevant GMP guidelines.|