Pfanstiehl - High-Purity, Low-Endotoxin Carbohydrates and Highly Potent APIs
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High-Purity, Low-Endotoxin Carbohydrates, Parenteral Grade Excipients and Highly Potent APIs

Pfanstiehl is a leading current good manufacturing practice (cGMP) manufacturer of parenteral grade excipients and highly potent APIs.

1219 Glen Rock Avenue,
Waukegan, IL,
60085-0439 United States of America

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.

Customized manufacturing services

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:

Chemical reaction expertise

  • Hydrolyses
  • Condensations
  • Chemical oxidations
  • Metal hydride reductions
  • Ruff degradations
  • Natural products isolation
  • Condensations
  • Commercial scale high potency substance (hps) containment manufacturing
  • Carbohydrate chemistry
  • Chiral chemistry
  • Esterification
  • Alkylations
  • Benzoylation
  • Acrylation
  • Etherification
  • Saponification
  • Oxidation
  • Sulfonation
  • Acid chlorination


  • Extraction / isolation
  • Selective crystallization
  • Ultrafiltration / nanofiltration
  • Deionization / electrodialysis
  • Activated carbon polishing and filtration
  • Chiral resolution

cGMP compliant process development, validation and manufacturing

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.

cGMP expertise

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.

Analytical services and process laboratories

The analytical services laboratory is equipped with modern analytical testing instrumentation, which includes:

  • Agilent 1200 HPLC-MS with APCI and ESI
  • Ten Agilent 1100 HPLCs (diode array, variable wavelength, refractive index and ELSD detectors)
  • Shimadzu Prominence HPLC with variable wavelength, refractive index, fluorescence detectors
  • Two Agilent GCs (6890 with headspace and split/splitless)
  • Shimadzu GCMS QP-2010
  • Thermo IRIS ICP-MS
  • Thermo-Nicolet Avatar 360 FTIR
  • Shimadzu UV-Vis spectrophotometer
  • Shimadzu spectrofluorometer
  • Milton-Roy refractometer
  • Mettler densitometer
  • Two Shimadzu TOC-V CSH analyzers (one with a ppm range and another featuring a ppb range)
  • Rudolph Autopol V polarimeter
  • Two automated Brinkman Karl Fisher titrators (Titrino 751 and Coulomat 831)
  • Two kinetic-turbidometric systems (Charles River-Endosafe and Cambrex/Lonza) for determining bacterial endotoxins (LAL testing)
  • Seven analytical balances and one microbalance
  • Several pH and conductivity meters
  • Sample management is accomplished using a validated 21 CFR part 11-compliant sample log in system
  • Chromatographic data management is performed by a validated 21 CFR part 11-compliant Waters Empower 2 system
  • Thermo ICP-MS ICAP Q

Our process chemistry lab has the following analytical instruments and lab equipment:

  • Three HP1100 HPLC with variable wavelength and refractive index detectors
  • AquaCounter AQV-300 automated volumetric Karl Fischer titrator
  • Sartorious MA 35 moisture analyzer balance
  • Mettler Toledo FP90 DSC and melting point apparatus
  • Biotage SP1 automated flash chromatography system
  • Parr 1-liter Hastelloy pressure reaction apparatus
  • Omnistation six-place 100ml reactor system
  • PUROSEP LT-1 benchtop ultrafiltration system

Galactose (NAD)

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.

Pfanstiehl Tradeshow Video

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.

Trehalose: A Powerful Excipient in the Formulation Toolbox

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 Launches New cGMP-Produced, Parenteral Grade Arginine

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.  

Pfanstiehl, Inc.

1219 Glen Rock Avenue

Waukegan, IL


United States of America