Description
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.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.
Our Quality Management System is ISO 9001:2015 certified.
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For further information or product requests, please contact us via our contact form or via email: support@pl-bioscience.com
