New Gamma Irradiated Human Platelet Lysate

GAMMA IRRADIATED HUMAN PLATELET LYSATE

ELAREM™ Ultimate-FD PLUS is a gamma irradiated, fibrinogen-depleted and anticoagulant-free Human Platelet Lysate of EU origin. As a xeno-free cell culture supplement, the product supports the efficient and safe in vitro expansion of primary cells and cell lines. The product is 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 a traceability over 30 years back to blood component. Each batch is produced from large pools of platelet units. Consequently, this ensures batch-to-batch consistency and enables reproducible conditions.

ELAREM™ Ultimate-FD PLUS is manufactured, tested and released in compliance with the relevant GMP guidelines. The manufacturing process for the product is patented.

Key points 

• Suited to cell manufacturing:  The product is suited to cell manufacturing applications requiring proven viral reduction, e.g. for potential use in clinical trials.

• Additional safety:  ELAREM™ Ultimate-FD PLUS ensures additional safety through a validated gamma irradiation process.

• Efficiency:  A viral clearance study demonstrates viral reduction for the tested viruses while preserving cell culture performance.

• GMP Grade:  ELAREM™ Ultimate-FD PLUS is manufactured, tested and released in compliance with the relevant GMP guidelines.

• Enhanced traceability:  By ensuring an EU-based raw material supply chain, we provide a traceability over 30 years back to blood component.

• Patent-protected:  The manufacturing process for the product is patented.

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