Technical Specifications & Documentation

Pharmaceutical-Grade Standards, Fully Verified and Traceable

GMP Certification
Every Celexir product—whether peptide, exosome, or cell-derived therapy—is produced in EU GMP-certified facilitiesoperating under strict ISO 9001 and ISO 13485 quality frameworks. Our manufacturing sites adhere to regulatory directives for Advanced Therapy Medicinal Products (ATMPs), and operate under an official Tissue Bank License and GMP Production License (e.g., License No. 3635).

The following documentation is available upon request or partner access:

• Certificate of Analysis (CoA) for each batch

• GMP certificates and production licenses

• Sterility validation reports (in accordance with EMA/CHMP standards)

• Stability and shelf-life data from accelerated and real-time studies

• Cold-chain integrity and temperature log reports for shipped products

This level of documentation transparency ensures full traceability and regulatory readiness across all export markets.

Quality Control & Testing
Celexir enforces a multi-point Quality Control (QC) system throughout the entire production pipeline—from raw material screening to final batch release. Each lot is tested using advanced analytical methods including:

• Identity Verification: HPLC (High-Performance Liquid Chromatography), Mass Spectrometry (MS), and peptide sequencing

• Sterility Testing: Conducted under aseptic cleanroom conditions per EU Pharmacopoeia guidelines

• Endotoxin Testing: Quantified via Limulus Amebocyte Lysate (LAL) assay to ensure safe systemic administration

• Heavy Metal Screening: Performed using ICP-MS where applicable

• Stability Testing: Real-time and accelerated testing for both refrigerated and ambient conditions

All tests are documented in batch-specific reports that meet EMA and ISO requirements for clinical and investigational use.