ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted Human Platelet Lysate of US origin. The GMP conform cell culture supplement is suited to clinical trial and therapeutic cell manufacturing needs.

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-FDidoes not require anticoagulant addition. Traces of a xeno-free anticoagulant 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.

ELAREM™ Ultimate-FDi is manufactured from platelet units obtained from healthy blood donors at licensed blood centres in the US.

Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.