ELAREM™ Ultimate-FD PLUS I GMP Grade

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

As a xeno-free cell culture supplement, ELAREM™ Ultimate-FD PLUS 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-FD PLUS is a clot-free and anticoagulant-free Human Platelet Lysate, eliminating the need to add anticoagulants in cell culture or during manufacturing. Combined with gamma-irradiation, this makes ELAREM™ Ultimate-FD PLUS especially suited to cell manufacturing applications requiring proven viral reduction, e.g. for potential use in clinical trials.

While all ELAREM™ Human Platelet Lysates are manufactured from screened platelet units, ELAREM™ Ultimate-FD PLUS ensures additional safety. Thus, the product undergoes gamma irradiation at a dose range of 38–55 kGy as a final manufacturing step. By conducting a viral clearance study, we demonstrated viral reduction for the tested viruses while preserving cell culture performance. ELAREM™ Ultimate-FD PLUS enables enhanced traceability throughout the entire product lifecycle. The Human Platelet Lysate is manufactured from platelet units obtained from healthy donors at licensed blood centres in the EU. By ensuring an EU-based raw material supply chain, we provide traceability over 30 years back to blood component.

ELAREM™ Ultimate-FD PLUS is manufactured under an ISO 9001:2015 certified Quality Management System and GMP-conform conditions within a closed system using sterile connections and high-quality raw materials. Each batch is manufactured from large pools of platelet units obtained from healthy blood donors at licensed blood centres in the EU. That ensures batch-to-batch consistency and enables reproducible conditions. Offered in 50 and 500 mL bottles.