ELAREM Ultimate-FD PLUS I GMP Grade

ELAREM Ultimate-FD PLUS I GMP Grade 

Application: ELAREM™ Ultimate-FD PLUS is a gamma irradiated, fibrinogen-depleted, anticoagulant-free human platelet lysate derived from EU-sourced platelet units. It is designed as a xeno-free cell culture supplement for safe and efficient in vitro expansion of primary cells and cell lines, with a focus on viral reduction suitable for clinical trial applications.

Product Details:

• Human Platelet Lysate (HPL), gamma irradiated at 38-55 kGy for viral inactivation
• Fibrinogen-depleted and anticoagulant-free formulation
• Large donor pools from licensed EU blood centres ensure batch consistency
• Manufactured under GMP guidelines using a patented process
• Traceability over 30 years to blood components
• ISO 9001:2015 certified Quality Management System
• Certificate of Analysis (CoA) and Safety Data Sheet (SDS) available on request.

Key Features:

• Supports robust and safe in vitro cell expansion
• Xeno-free, suitable for clinical and research settings
• Proven viral reduction through gamma irradiation and viral clearance
• Compliant with EU sourcing and GMP manufacturing standards
• High batch consistency from pooled donor sources

Applications:

• Cell therapy manufacturing and clinical research
• Expansion of mesenchymal stem cells, primary cells, and cell lines
• Xeno-free media supplement for cell culture
• Translational research and clinical trial workflows

Expiry date: August 2026