HPL ELAREM™ Ultimate FDi GMP Grade Gamma Irradiated, fibrinogen depleted, no heparin required

ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted human Platelet Lysate of US origin. The xeno-free cell culture supplement is suited to clinical trial and therapeutic development needs.

ELAREM™ Ultimate-FDi combines excellent cell performance rates and a high safety level, both necessary for industrial in vitro cell expansion.

ELAREM™ Ultimate-FDi is manufactured, tested and released in compliance with the relevant GMP guidelines. The final product is gamma-irradiated at a dose of 25~40 kGy 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 heparin addition. As a result, application workflows are simplified. Traces of a xeno-free heparin may be present in the human Platelet Lysate.

Each batch of ELAREM™ Ultimate-FDi is produced from large pools of platelet units to ensure batch-to-batch consistency and enable reproducible conditions.

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