Technical Specifications and Documentation
From GMP certification to batch-level quality reports, every Celexir product is backed by rigorous documentation and pharmaceutical-grade testing. Our transparent approach ensures full traceability, sterility, and compliance—giving your clinic total confidence in every dose.
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.