Galactose (NAD)
Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides.
High-Purity, Low-Endotoxin Carbohydrates, Parenteral Grade Excipients and Highly Potent APIs
1219 Glen Rock Avenue,
Waukegan, IL,
60085-0439 United States of America
Pfanstiehl is a leading current good manufacturing practice (cGMP) manufacturer of parenteral grade excipients and highly potent active pharmaceutical ingredients (API).
Pfanstiehl develops and manufactures high-purity, low-endotoxin (HPLE) carbohydrates such as trehalose, sucrose, mannitol, galactose, maltose and mannose utilized as injectable excipients for the stabilization of proteins, mAbs and vaccines. These HPLEs are also used as supplements for industrial cell culture, cell therapy and cryopreservation media.
Pfanstiehl works closely with many of the world’s largest multinational pharmaceutical and biopharmaceutical firms, as well as virtual pharmaceutical companies, to synthesize proprietary and commercial compounds in quantities ranging from grams to tonnes.
Pfanstiehl has a 40-year history in custom synthesis, custom manufacturing and process scale-up development. The company is based near Chicago, Illinois, US.
Whether you are working at an innovator company on a novel formulation or at a biosimilar firm trying to replicate an existing tried and true formulation, consider Pfanstiehl as your pure source for a plug and play solution.
Pfanstiehl can provide custom synthesis of new chemical entities (NCE), specialty carbohydrates and injectable-quality, cGMP pharmaceutical ingredients in commercial quantities. Our capabilities include process scale-up, development and process validation, according to cGMP guidelines. Our facilities and equipment are configured to produce HPLE compounds, including potent (highly active toxic or cytotoxic) drugs under cGMP conditions.
As a long-time manufacturer of low-endotoxin carbohydrates, injectable grade excipients, active pharmaceutical ingredients (API) and pharmaceutical intermediates, Pfanstiehl can establish and maintain US and European drug master files (DMF) and European ‘Certificates of Suitability’ for your product. Pfanstiehl is here to help you get your compound to market, seamlessly bridging the critical gap between product development and regulatory approval.
To suit your needs we perform a wide range of chemistries and purification techniques, including but not limited to:
With over 40 years of cGMP manufacturing experience, Pfanstiehl has prepared the necessary documentation, validation and qualification systems to ensure compliance with the FDA and other regulatory bodies worldwide. Maintaining more than 15 DMFs for customers and for Pfanstiehl proprietary APIs, our services include cGMP manufacturing and cGMP-compliant process development and validation.
Pfanstiehl’s facilities are FDA registered and inspected with over 15 active DMFs, which include US Type II, Canadian and European DMFs and Certificates of Suitability. Fully qualified equipment and utilities are used in the cGMP manufacturing areas, in addition to cGMP development and scale-up services.
Experienced manufacturing, quality assurance and regulatory affairs teams are available to provide support and advice during the devlopment process.
The analytical services laboratory is equipped with modern analytical testing instrumentation, which includes:
Our process chemistry lab has the following analytical instruments and lab equipment:
Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides.
Mannitol is classified as a sugar alcohol and is derived from a sugar (mannose) by reduction. Other widely known polyols are xylitol and sorbitol.
Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose, found in many plants but extracted as ordinary sugar mainly from sugar cane and sugar beets.
Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond.
Vice-president of research and development (R&D) Dr. Trevor Calkins discusses Pfanstiehl’s active pharmaceutical ingredients (API) contract development and manufacturing organisation (CDMO) philosophy and capabilities at the CPhI/InformEx.
In this white paper, Trevor Calkins and Nancy Coffman study the uses of parenteral-grade sucrose in biomolecule development.
In the pharmaceutical industry, products that benefit from the stabilising effects of trehalose include, but are not limited to, monoclonal antibodies (mAb), antibody drug conjugates (ADC), fusion proteins, peptides, stem cells and vaccines.
Pfanstiehl has announced that it will be sponsoring the 2019 Colorado Protein Stability Conference.
Sucrose, trehalose, mannitol and maltose are four of the most commonly utilised carbohydrates for protein stabilisation in drug formulations.
Pfanstiehl has announced it will be attending the AAPS PharmSci 360 conference.
As Pfanstiehl approaches its 100th anniversary in 2019, the company has launched a new high-purity, low-endotoxin, and low-metal L-Arginine to meet US Pharmacopoeia (USP), European Pharmacopoeia (EP), Japan Pharmacopoeia (JP), and Chinese Pharmacopoeia (ChP) standards.
As part of Pfanstiehl’s continual commitment to producing high-purity, low-endotoxin and low-metal (HPLE-LM) offerings for bioprocessing components, two new D-Galactose products were launched.
Pfanstiehl will be attending PepTalk: the Protein Science Week from 19-23 January 2015 in San Diego.
Pfanstiehl has announced the launch of a new high-purity, low-endotoxin, Mannitol, which is manufactured in the US under strict current good manufacturing practices (cGMP) and ICH Q7 compliant conditions.
Pfanstiehl has announced the launch of cGMP-produced, high purity Mannose (USP/NF, EP), manufactured in the US under ICH Q7 compliant conditions.
Pfanstiehl is aggressively investing in its potent API contract manufacturing capabilities at its US-based cGMP facility located north of Chicago, US.
Pfanstiehl just announced the launch of its new high purity, low endotoxin, non-animal-derived Galactose (USP/NF, EP), manufactured in the US under strict cGMP, ICH Q7-compliant conditions.
1219 Glen Rock Avenue
Waukegan, IL
60085-0439
United States of America