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LATEST PRESS RELEASES
May 14, 2019

Pfanstiehl Launches cGMP-Produced, Parenteral-Grade Mannitol

Pfanstiehl has announced the launch of a high-purity, low-endotoxin and low-metal Mannitol, which is manufactured in the US under strict...
pharmacuetical business review
March 7, 2019

Profiling Metal Content in Parenteral Grade Protein Stabilisers

Sucrose, trehalose, mannitol and maltose are four of the most commonly utilised carbohydrates for protein stabilisation in drug formulations.
pharmacuetical business review


LATEST VIDEOS

Pfanstiehl Tradeshow Video

Pfanstiehl

Pfanstiehl provides parenteral-grade excipients and highly potent active pharmaceutical ingredients (API) in accordance with current good manufacturing practice (cGMP) guidelines.

Pfanstiehl provides parenteral-grade excipients and highly potent active pharmaceutical ingredients (API) in accordance with current good manufacturing practice (cGMP) guidelines.

The company develops high-purity, low-endotoxin (HPLE) carbohydrates such as trehalose, sucrose, mannitol, galactose, maltose and mannose for use as injectable excipients for the stabilisation of proteins, monoclonal antibodies (mAb) and vaccines.

Pfanstiehl’s HPLEs are used as supplements for industrial cell culture, cell therapy and cryopreservation media.

CDMO manufacturer of injectable excipients

Pfanstiehl works closely with many of the world’s largest multinational pharmaceutical and biopharmaceutical firms, as well as virtual pharmaceutical companies.

It synthesises proprietary and commercial compounds in both large and small quantities.

Pfanstiehl has a 40-year history in custom synthesis, manufacturing and process scale-up development.

Novel formulation development for APIs

Pfanstiehl provides high-quality plug-and-play solutions to biosimilar and pharmaceutical firms worldwide. It provides custom synthesis of new chemical entities (NCE), speciality carbohydrates and injectable-quality, cGMP pharmaceutical ingredients in commercial quantities.

The company’s capabilities include process scale-up, development and process validation, according to cGMP guidelines. Its 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. Pfanstiehl helps you get your compound to market, bridging the gap between product development and regulatory approval.

Chemical reaction and purification expertise

Pfanstiehl performs a wide range of chemistries to meet client requirements, including:

  • 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

Pfanstiehl’s purification offerings include extraction and isolation, selective crystallisation and ultrafiltration / nanofiltration, as well as deionisation, electrodialysis, activated carbon polishing and chiral resolution.

cGMP compliant process development, validation and manufacturing

With more than 40 years’ 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, the company’s services include cGMP manufacturing and cGMP-compliant process development and validation.

cGMP expertise

Pfanstiehl’s facilities are FDA registered and inspected with more than 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

The company’s process chemistry lab has the following analytical instruments and lab equipment, including:

  • 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

Contact

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

Tel: +1 847 623 0370
Fax: +1 847 623 9173
Email: cs@pfanstiehl.com
www.pfanstiehl.com/api

 

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Galactose (NAD)

Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides.

Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides. It is found in milk, sugar beets, gums, and mucilages. It is also synthesized in humans, and is a constituent of glycolipids and glycoproteins. Galactose is finding an ever-increasing use as a cell metabolism modulator in the…

Mannitol

Mannitol is classified as a sugar alcohol and is derived from a sugar (mannose) by reduction. Other widely known polyols are xylitol and sorbitol.

Mannitol is classified as a sugar alcohol and is derived from a sugar (mannose) by reduction. Other widely known polyols are xylitol and sorbitol. Mannitol and sorbitol are isomers, differing only in the orientation of the hydroxyl group on carbon two. The physical properties of mannitol make it suitable for use as a bulking agent…

Sucrose

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.

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. Pfanstiehl brand, high-purity low endotoxin (HPLE) Sucrose is used in the biopharmaceutical industry to stabilise proteins, lipids, and carbohydrates throughout the formulation and freeze / thaw lifecycle…

Trehalose

Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond.

Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond. Pfanstiehl brand high-purity low endotoxin (HPLE) Trehalose is used in the biopharmaceutical industry to stabilise proteins, lipids, and carbohydrates throughout the formulation and freeze / thaw lifecycle of therapeutics. It is also widely applied as a key component in…
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Pfanstiehl Launches cGMP-Produced, Parenteral-Grade Mannitol

Pfanstiehl has announced the launch of a high-purity, low-endotoxin and low-metal Mannitol, which is manufactured in the US under strict...
14th May 2019

Profiling Metal Content in Parenteral Grade Protein Stabilisers

Sucrose, trehalose, mannitol and maltose are four of the most commonly utilised carbohydrates for protein stabilisation in drug formulations.
7th March 2019

Pfanstiehl to Attend AAPS PharmSci 360 Conference

Pfanstiehl has announced it will be attending the AAPS PharmSci 360 conference.
31st October 2018

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...
6th September 2018

Pfanstiehl Launches Parenteral-Grade Sodium Succinate

Pfanstiehl has announced the launch of the first cGMP Sodium Succinate Hexahydrate (NF) to the market, which is compliant with the new USP Monograph...
4th September 2018

Pfanstiehl D-Galactose Products for Cell Culture Media Optimisation

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...
8th June 2018
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Pfanstiehl Tradeshow Video

Published on May 14, 2019
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