Sourcing & Handling Protocols

EU-Compliant Standards for Safety, Traceability, and Efficacy

Tissue & Cell Sourcing
Celexir’s regenerative biologics—including mesenchymal stem cells (MSCs) and exosome products—are derived exclusively from allogeneic human donors who have undergone comprehensive medical screening at licensed clinical partner sites. All procurement activities adhere strictly to the EU Tissues and Cells Directive (2004/23/EC) and its implementing directives (2006/17/EC and 2006/86/EC), which mandate:

• Full donor medical history and infectious disease screening

• Identity confirmation and consent documentation

• End-to-end traceability of human-origin materials

• Compliance with safety thresholds for tissue processing and storage

These guidelines ensure that every biological product meets the highest possible standards for donor eligibility, ethical sourcing, and contamination prevention.

Processing
All collected materials are processed in our GMP-certified Advanced Therapy Medicinal Products (ATMP) facility in Vilnius, Lithuania (License No. 3635). Our facility operates a closed-loop tissue banking system, audited to ISO 9001and EU ATMP standards. Each batch undergoes:

• Aseptic processing in ISO-classified cleanrooms

• Sterility and endotoxin testing

• Quality control protocols aligned with EMA guidelines

• Real-time and retrospective batch traceability

This system ensures the molecular integrity, purity, and clinical readiness of every product before it enters application or shipment.

Storage
Celexir utilizes pharmaceutical-grade cryopreservation protocols, allowing for long-term biological storage while maintaining cell viability, functional performance, and therapeutic potency. Our cryo-banking platform is engineered for:

• Storage durations of up to 20 years

• Validated temperature controls and redundancy systems

• Regulatory-aligned documentation for each stored sample

This guarantees that each unit is stable, retrievable, and fully viable at the point of clinical use or export.