PFANSTIEHL, INC.
1219 Glen Rock Ave
Waukegan, IL 60085
T: (847) 623-0370 Toll Free (800) 383-0126
E: cs@pfanstiehl.com
W: www.pfanstiehl.com
Pfanstiehl is a global leader in the manufacture of cGMP-compliant, high-purity, low-endotoxin, low-metal injectable grade excipients and biopharmaceutical components, designed for use in upstream & downstream bioprocessing, and final drug formulation. Additionally, Pfanstiehl is a leading Contract Development and Manufacturing Organization (CDMO), specializing in the isolation, purification, custom synthesis, and scale-up of small molecule Active Pharmaceutical Ingredients (APIs) from gram to multi-ton commercial quantities. Unlike many manufacturers or resellers who serve a variety of industries such as food, cosmetics, agriculture, or nutritional supplements, Pfanstiehl focuses exclusively on biopharmaceutical applications.
Pfanstiehl’s ICH Q7-compliant and US FDA-inspected manufacturing facility is strategically located just north of Chicago, a 35-minute drive from O’Hare International Airport. The company’s product offerings include platform-enabling parenteral-grade, multi-compendial protein and cell membrane stabilizers such as Trehalose, Sucrose, Arginine, and Maltose, as well as Mannitol and Sodium Succinate Hexahydrate, all crucial for formulation optimization. Recent additions to the portfolio include amino acids such as Histidine, Methionine, Glutamine, and TRIS base, with plans to expand further in response to client feedback. Pfanstiehl collaborates with clients seeking more than just high-quality ingredients, offering partnership in navigating evolving regulatory requirements and addressing emerging formulation challenges.
For upstream applications, Pfanstiehl offers high-purity, low-endotoxin, low-metal galactose to reduce lactate and ammonia production, which enhances overall cell culture performance. The company provides multiple types of D-Galactose, including non-animal-derived options. Mannose is also available to improve native glycosylation and ensure consistent product quality, particularly in high-titer processes.
Founded in 1919, Pfanstiehl celebrates over a century of excellence in carbohydrate and process chemistry. The company supplies many of the world’s leading biopharmaceutical, vaccine, and pharmaceutical companies, with products utilized in treatments for life-threatening diseases such as cancer, rheumatoid arthritis, STDs, and diabetes, as well as in leading vaccine platforms, including mRNA and viral vector-based vaccines.
Pfanstiehl’s commitment to stringent regulatory standards and high-purity manufacturing is recognized by the FDA and other global regulatory agencies. The company prioritizes product quality, environmental responsibility, and worker safety, designing facilities and training personnel to exceed US FDA, cGMP, OSHA, and international standards. Pfanstiehl is dedicated to ensuring the quality, purity, and safety of its excipients, as well as the security of supply for its clients.
For more information, please visit our website at Pfanstiehl.com.
Posted Date: 12/1/2024
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