Ferro Pfanstiehl Laboratories is recognized globally as a reliable producer of commercial quantities of high purity, rare and specialized carbohydrates / sugars. All of our cataloged products have been developed to meet our customers' specific requirements.
Our key capabilities go beyond our expertise in carbohydrate chemistry. We have unique expertise in:
- performing complex chemistries at commercial scale,
- isolating rare sugars from natural botanical sources, and
- purifying rare sugars utilizing unique and proprietary chromatographic, filtration and crystallization techniques.
We know where and how to source unique carbohydrate raw material feed stock to assure that your new product pipeline is supportable and economically viable.
High Purity Low Endotoxin Carbohydrates
Sugars are widely used for isolation of proteins, as well as production of proteins in unique ways. Most sugars used in injectable protein-based drugs and vaccines are currently lot -selected, food-grade derived products and are not tested or standardized to the levels sufficient for parenteral use in the future, from a regulatory risk perspective. Contaminants, including heavy metals, microbes and bacterial endotoxins can lead to poor yields, reduced protein stability or side effects, including death in patients.
A leading manufacturer of High Purity Low Endotoxin (HPLE) sugars for more than 40 years, FPL supplies most of the disaccharide sugars used in human plasma-derived and other injectable protein biopharmaceutical formulations. FPL’s Galactose, Maltose, Sucrose and Trehalose, manufactured under ICH-Q7A, help assure cGMP compliance to API standards for injectable products and ingredients in today’s “risk-based” regulatory environment.
FPL’s HPLE products are manufactured from the highest purity commercially available raw materials and further processed under cGMP conditions suitable for the manufacture of Regulated Injectable Formulation Grade Ingredients. Where commercial sources are not available, carbohydrates are isolated from botanical sources or manufactured via fermentation. FPL achieves its HPLE levels using a combination of proprietary purification techniques. The Quality Assurance and Regulatory Affairs departments are able to maintain product specifications and DMFs according to the needs of its clients and all applicable regulatory agencies.
To explore a collaboration, contact us or call 1-800-383-0126.