Ultra-high purity, low-endotoxin carbohydrates are needed when even the lowest level of contaminants — especially endotoxins (cell wall fragments of gram negative bacteria) and other high-molecular weight impurities — can compromise the final product's purity, biological activity, shelf life, and/or patient safety.

Ultra-Pure, Low-Endotoxin Carbohydrates for Pharmaceutical and Biotechnology Applications

Ultra-high purity, low-endotoxin carbohydrates are utilized:

• to stabilize lyophilized therapeutic protein biopharmaceuticals for injectable drug formulation 
• as high-purity processing aids in blood protein fractionation (separation / purification)
• as high purity nutrients in mammalian cell culture growth media, as stabilizing-high purity bulking agents for lyophilized enzymes and proteins.

Ferro Pfanstiehl Carbohydrate Uses

1. Therapeutic Protein Biopharmaceutical Stabilization
2. Therapeutic Protein Biopharmaceutical Formulation Bulking Agents
3. Human Plasma Derived Protein Fractionation and Formulation Processing Aids
4. Blood Platelette Stabilization
5. Cell Culture Fermentation Media Nutrients

Ferro Pfanstiehl's High Purity and Low Endotoxin Products are manufactured from the highest purity commercially available raw materials and are further processed under cGMP conditions suitable for the manufacture of Regulated Injectable Formulation Grade Ingredients.

Manufacturing Processes

To meet purity specifications for all critical applications, Ferro Pfanstiehl subjects commercially available, bulk carbohydrates to rigorous purification techniques. Where commercial sources of sugars are not available, we isolate the carbohydrates from botanical sources.

Dependent upon the carbohydrate and its application, Ferro Pfanstiehl achieves high-purity and low-endotoxin levels using any combination of proprietary purification techniques. These commercial scale processes include: deionization, ultra-filtration, nanofiltration, activated carbon treatment / electrodialysis, and dissolution / recrystallization.

Drug Master Files (DMFs)

Ferro Pfanstiehl develops and maintains its product specifications and regulatory support documentation according to the level of our customers' use requirements. Our Quality Assurance and Regulatory Affairs departments will establish and maintain product specifications and Drug Master Files to meet your needs.

To explore a collaboration, contact us or call 1-800-383-0126.