Pfanstiehl Is Focused
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.
Pfanstiehl’s has continually committed to producing the industry’s highest purity, lowest endotoxin, lowest metal, platform-enabling protein and cell membrane stabilizers which include Trehalose, Sucrose and the newly launched Mannitol and Sodium Succinate. These products are produced in our ICH Q7-compliant manufacturing facility in the U.S. and have market leading specifications which include ICH Q3D Elemental Impurity Data. Pfanstiehl is significantly expanding its products and solutions portfolio in 2018 and beyond to include other key excipients based on feedback from our clients.
As we are entering into a new era of increased regulatory scrutiny, Pfanstiehl’s Know Your Products & Processes Program, has resulted in product characterization data that enables us to stay ahead of new regulatory requirements. We offer full product characterization data to our clients free of charge, understanding the criticality of such information. This shows our commitment to our clients and their success, as we deliver World Class Levels of Quality and Consistency.
We offer full product characterization data to our clients free of charge, understanding the criticality of such information.
For upstream applications, Pfanstiehl manufactures and recently launched a new high purity, low endotoxin, low metal D-Galactose. Galactose is a key component in cell culture media, which helps to optimize protein production while mitigating lactate and ammonia formation. Galactose is used as a cell metabolism modulator and helps to increase yields, which is why Galactose utilization is growing in our biopharmaceutical market. Pfanstiehl has implemented specifications for the new Galactose to recognize a tighter control strategy, which provides product consistency and better support for biopharmaceutical upstream processing requirements. The specification will exceed regulatory requirements and reflects Pfanstiehl’s leadership in setting the industry standards with our high purity, low endotoxin, low metal Excipient products and solutions. Complimentary samples from Pfanstiehl’s cGMP validation batches of Galactose are available for customer qualification activities, along with a Product Profile and extensive product characterization data. Trehalose can also be utilized in upstream bioprocessing and cell therapy applications to reduce protein aggregation and improve cell robustness.
Pfanstiehl is also a cGMP Contract Development and Manufacturing Organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule High Potency Active Pharmaceutical Ingredients and Active Pharmaceutical Ingredients. Pfanstiehl has recently completed upgrades to our API manufacturing operations and can produce grams to multi-ton commercial quantities. We specialize in carbohydrates, nucleosides, and New Chemical Entities (NCEs). With over 50 years of experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.
Pfanstiehl also manufactures generic API’s such as Streptozotocin and has several new products under development. In addition, Pfanstiehl offers large volume parenterals, including Sodium and Ammonium Lactates, manufactured right here in the Unites States. These products are also high purity, and have low endotoxin and low metals for parenteral grade injection, with DMF support in the US and around the world.
Founded in 1919, Pfanstiehl will soon celebrate its 100th year anniversary as a leader in carbohydrate and process chemistry. Since under new ownership in 2013, significant investments and improvements continue to be made. Pfanstiehl’s customers include 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, diabetes, etc., and have been administered to thousands of patients around the world.
Pfanstiehl has terrific track record with the FDA! As an API and Excipient manufacturer, Pfanstiehl is inspected regularly by the US FDA. We work diligently to ensure that our facility and systems are inspection ready and compliant with regulatory requirements. As an API manufacturer, FDA inspections of our facility are extensive in nature and cover many segments of our quality system; Production System, Facilities and Equipment Systems, Laboratory Controls System, Materials System, and Packaging/Labeling System. Our recent inspection covered process validation, CAPA, packaging and labeling, materials management, root cause analysis, risk assessment, software validation, 21 CFR Part 11 compliance, and laboratory controls and method development. No FDA Form 483 observations were issued and no Discussion points were made, in the recent FDA audit completed in October 2017. Pfanstiehl's quality system is based on ICH Q7. We apply the same quality system to our APIs as we do to our Excipients! Pfanstiehl is committed to regulatory compliance excellence and ensuring that our customers can be confident in the products they purchase.
We welcome our customers to come and audit our facilities, so we can show you first hand our commitment to quality and safety.
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 own procedures and train our people to meet or exceed US FDA, cGMP, ICH Q7, OSHA, and international regulatory and multi-compendial standards (including Chinese Pharmacopeia).
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