ELAREM™ Ultimate-FDi I GMP Grade

ELAREM™ Ultimate-FDi GMP Grade is a fibrinogen-depleted, anticoagulant-free Human Platelet Lysate of US origin, additionally subjected to gamma-irradiation for viral reduction.

As a xeno-free cell culture supplement, ELAREM™ Ultimate-FDi supports the efficient and safe in vitro expansion of various primary cells and cell lines under GMP-compliant conditions. Due to a unique fibrinogen-depletion technique, ELAREM™ Ultimate-FDi is a clot-free and anticoagulant-free Human Platelet Lysate, eliminating the need to add anticoagulants in cell culture or during manufacturing. Combined with terminal γ-irradiation, this makes ELAREM™ Ultimate-FDi a ready-to-use, viral-reduced HPL suited to regulated cell-therapy manufacturing.

ELAREM™ Ultimate-FDi is manufactured, tested and released in compliance with the relevant GMP guidelines. The 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).

Due to the fibrinogen-depletion process, ELAREM™ Ultimate-FDi does not require anticoagulant addition. Traces of a xeno-free anticoagulant may be present in the Human Platelet Lysate. Each batch is manufactured from large pools of platelet units obtained from healthy blood donors at licensed blood centres in the US. That ensures batch-to-batch consistency and enables reproducible conditions. Offered in 50, 100 and 500 mL bottles.