High‑Purity Verification of Recombinant Human Holo‑Transferrin

High‑Purity Performance Verification of Recombinant Human Holo‑Transferrin 

To intuitively verify the purity level and impurity‑control capability of our recombinant human holo‑transferrin, purity characterization tests were performed at a standard cell‑culture working concentration of 0.01 g/mL. Dual validation by SDS‑PAGE and Size‑Exclusion High‑Performance Liquid Chromatography (SEC‑HPLC) fully demonstrates the product’s core strengths of ultra‑high purity, zero exogenous impurities and intact molecular structure. It is applicable to stringent scenarios including PBMC expansion, iPSC culture, immune cell expansion, and raw/excipient materials for cell and gene therapy (CGT).

1. Test Conditions
Test Sample: Recombinant Human Holo‑Transferrin
Test Concentration: 0.01 g/mL (conventional working concentration for cell culture)
Detection Methods: SDS‑PAGE gel electrophoresis, SEC‑HPLC
Detection Indicators: Protein purity, impurity proteins/degradation fragments, host‑cell protein residues, endotoxins, exogenous contaminants

2. Purity Test Results (at 0.01 g/mL)
At the low concentration of 0.01 g/mL, our recombinant holo‑transferrin shows a single clear protein band with no impurity bands, degradation fragments or protein aggregates/precipitates. SEC‑HPLC results present a sharp, symmetric main peak free of miscellaneous peaks, with protein purity ≥98%.
Meanwhile, the product contains no endotoxins, host‑cell residues, animal‑derived components or blood‑borne viral contaminants, achieving complete freedom from impurity interference.

3. Core Advantages of Ultra‑High Purity

• Ultra‑high Purity with Zero Residual Impurities
  It maintains high homogeneity even at 0.01 g/mL, free of impurity proteins, degradation products and exogenous contaminants. Far superior to plasma‑derived transferrin, it completely avoids risks of impurities, viruses and batch‑to‑batch variations from blood‑sourced products.
• Stable Molecular Structure for Cell Culture Compatibility
  Manufactured through full‑process recombinant expression and multi‑step chromatographic purification, the protein possesses an intact spatial structure and stable iron‑binding function. With good solubility and no aggregation at 0.01 g/mL, it stably supports PBMC expansion, iPSC stemness maintenance and immune cell culture.
• Safe & Compliant with Strict CGT Standards
  Free of animal‑derived components, pyrogens and antibiotic residues, it has strictly controlled impurity indicators and meets compliance requirements for raw/excipient materials of cell and gene therapy drugs.
• Excellent Batch‑to‑Batch Consistency & Large‑Scale Supply
  Produced with ton‑scale industrial production and standardized purification processes, it achieves highly consistent purity and activity across batches, enabling stable long‑term supply.

4. Conclusion
At the standard working concentration of 0.01 g/mL, our recombinant human holo‑transferrin features ultra‑high purity, zero impurities, high stability and high safety. As a reliable substitute for plasma‑derived transferrin, it supplies high‑quality, safe and stable core raw materials for stem cell culture, immune cell expansion and CGT raw/excipient material development.

Key Quality Specifications

Important Notice