Pfanstiehl is a global leader in the manufacture of cGMP high purity, low endotoxin, low metal injectable-grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis, and scale-up development of small molecule Active Pharmaceutical Ingredients (APIs), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries, such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of ‘pharma- grade’ ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7-compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.
Pfanstiehl’s tried and true, platform-enabling protein and cell membrane stabilizers include Trehalose, Sucrose, Arginine, and Maltose. Parenteral-grade, multi-compendial Mannitol and Sodium Succinate are also offered as key tools for formulation optimization. We are continuing to expand this portfolio to include other key excipients based on feedback from our clients who want real cGMP manufacturing from a company that understands and supports their requirements. Many clients are not simply looking for a high-quality source of consistent ingredients, but seek a partner who can adapt to the ever-evolving regulatory landscape and address emerging formulation challenges collaboratively.
For upstream applications, Pfanstiehl manufactures high purity, low endotoxin, low metal galactose for reduction of lactate and ammonia production. Overall cell culture performance improvements can be achieved with optimized titration of galactose in lieu of other carbon sources. Pfanstiehl offers multiple types of galactose, including a non-animal- derived product. Mannose is also offered as a high purity cell culture supplement to improve native glycosylation and improve consistency in product quality attributes, particularly in high titer processes. Trehalose can be utilized in upstream bioprocessing and cell therapy applications to reduce protein aggregation and improve cell robustness.
Pfanstiehl was founded in 1919 and is celebrating its 100-year anniversary as a leader in carbohydrate and process chemistry. Pfanstiehl’s customers include most of the world’s leading biopharmaceutical and pharmaceutical companies. Our products are utilized in market-leading drugs that treat life-threatening and debilitating diseases, including cancer, rheumatoid arthritis, STDs, and diabetes. Increasing regulatory and quality requirements are benefiting high integrity biopharmaceutical and pharmaceutical suppliers like Pfanstiehl with high purity, strong cGMP controls and a strong reputation with FDA and other regulatory agencies. In everything we do, Pfanstiehl is motivated by a concern for both product quality and environmental/worker safety. We design and equip our plant, write our procedures and train our people to meet or exceed US FDA, cGMP, OSHA and international regulatory and multi-compendial standards.
Posted Date: 12/1/2021
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