Pfanstiehl 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 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
- Chemical oxidations
- Metal hydride reductions
- Ruff degradations
- Natural products isolation
- Commercial scale high potency substance (hps) containment manufacturing
- Carbohydrate chemistry
- Chiral chemistry
- 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.
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
Products and Services
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.
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 (mAbs), antibody drug conjugates (ADCs), fusion proteins, peptides, stem cells and vaccines.
Narrowing the Gap Between Active Ingredients and Critical Excipients
The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component.
Closing Characterisation Gap Between API and Formulation Components
This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limited functionality with the new paradigm, which suggests these components play a significant role in therapeutic stability, quality, potency, immunogenicity, and bioavailability.
Validated Metal Analysis of Injectable Grade Platform Excipients
Four commonly utilized carbohydrates for ptotein stabilization are Sucrose, Trehalose, Mannitol, and Maltose.
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.Read more
Pfanstiehl will be attending PepTalk: the Protein Science Week from 19-23 January 2015 in San Diego.Read more
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.Read more
Pfanstiehl Launches cGMP-produced Mannose for Cell Culture Media Optimization and Glycoprotein Biosynthesis
Pfanstiehl has announced the launch of cGMP-produced, high purity Mannose (USP/NF, EP), manufactured in the US under ICH Q7 compliant conditions.Read more
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.Read more