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ELAREM™ Ultimate-FDi

ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted human platelet lysate. Ultimate-FDi is a clinical-grade supplement suited for therapeutic cell manufacturing requiring gamma-irradiation and viral panel testing. GMP-grade, Drug Master File, and US origin.

Grouped product items
SKU	SIZE	PRICE	QTY
UL40822	100 mL	$725.00	- +
UL41022	500 mL	$3,350.00	- +

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Description

Specifications

More Information
SKU	ELAREM-FD
Intended use	Media supplement, cell culture, cell therapy research, drug discovery, MSCs, T Cells, Hematopoietic Stem Cells, and iPSCs
Endotoxin	< 10.0 EU/mL
Shelf-Life	18 months from date of manufacture
Storage	Store at -20°C
Total Protein	4.0 - 8.0 g/dL
Source	US donors, AABB-accredited and FDA-registered blood banks
Viral Testing	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).
Biological Testing	Tested and released in compliance with the relevant GMP guidelines.

ELAREM™ Ultimate-FDi is a virus-inactivated and fibrinogen-depleted human platelet lysate manufactured under cGMP and suited for cell-based research and cell therapy applications. ELAREM™ Ultimate-FDi is gamma-irradiated which provides a high penetration depth of ionizing radiation and is effective against a wide range of viruses. Gamma-irradiation and viral panel testing is performed according to ICH and EMA guidelines (ICH Q5A (R1) and CPMP/BWP/268/95).

Features

Developed for clinical and therapeutic applications.
Xeno-free cell culture supplement supports rapid cell expansion.
A growth factor rich, heparin-free supplement that is a superior alternative to FBS.

Due to the fibrinogen-depletion process, ELAREM™ Ultimate-FDi does not require an anticoagulant addition. Each batch is produced from large pools of platelet units and is manufactured from healthy blood donors obtained from licensed blood centers in the US.

Resources

Documents

Brochure: Human Platelet Lysate for Cell Therapy Research

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