News

September 4, 2018
Pfanstiehl Launches a new cGMP-produced, Parenteral Grade Sodium Succinate (Hexahydrate) for Biopharmaceutical and Pharmaceutical Formulations
Pfanstiehl has announced the launch of the first cGMP Sodium Succinate Hexahydrate (NF) to the market, which is compliant with the new USP Monograph established in 2017. Pfanstiehl previously launched the first cGMP Sodium Succinate Anhydrous (NF) to the market in March 2018. This is the only available cGMP grade Sodium Succinate Hexahydrate (#D-161) product available on the market. It is highly pure, has low endotoxin and is manufactured in the US under strict ICH Q7 compliant conditions.
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July 20, 2018
Pfanstiehl Launches a new cGMP-produced, Parenteral Grade Arginine For Biopharmaceutical and Pharmaceutical Formulations
As Pfanstiehl approaches its 100th anniversary in 2019, the company has launched a new high purity, low endotoxin, and low metal L-Arginine (USP, EP, JP, ChP), manufactured in the United States under strict cGMP, ICH Q7 compliant conditions. This is the first amino acid Pfanstiehl has launched and they have others in development.
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March 9, 2018
Pfanstiehl Launches a new cGMP-produced, Parenteral Grade Sodium Succinate (Anhydrous) for Biopharmaceutical and Pharmaceutical Formulations
Pfanstiehl has announced the launch of the first cGMP Sodium Succinate Anhydrous (NF) to the market, which is compliant with the new USP Monograph established in 2017. This is the only available cGMP grade Sodium Succinate product available on the market. It is highly pure, has low endotoxin and is manufactured in the US under strict ICH Q7 compliant conditions.
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January 19, 2018
Pfanstiehl Launches a new cGMP-produced, Parenteral Grade Mannitol For Biopharmaceutical and Pharmaceutical Formulations
Pfanstiehl has announced the launch of a new high purity, low endotoxin, and low metal Mannitol (USP, EP, JP, ChP), manufactured in the US under strict cGMP, ICH Q7 compliant conditions. Mannitol is a tried and true platform excipient used in a wide range of therapeutic formulations. Mannitol has demonstrated its utility as a stand-alone lyo-protectant or bulking agent, as well as in combination with other high purity excipients like Trehalose and Sucrose to stabilize a variety of systems including mAbs, ADCs, vaccines, and small molecules.
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November 15, 2017
Pfanstiehl Launched a new cGMP-produced Galactose for Cell Culture Media Optimization & Production of Therapeutic Recombinant Glycoproteins
As part of Pfanstiehl’s continual commitment to producing the industry’s highest purity, lowest endotoxin and lowest metals for bioprocessing components, two new D-Galactose products have been launched. Pfanstiehl’s new D-Galactose (Plant Derived) High Purity / Low Endotoxin – Low Metal, EP (G-126-3) product and D-Galactose (Plant Derived) High Purity / Low Endotoxin (G-126-2) product are now available for commercial sale.
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November 30, 2015
Pfanstiehl Establishes Asian Subsidiary
Pfanstiehl, a leading US-based manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications, has announced the establishment of its Asian subsidiary, Pfanstiehl Singapore Pte. Ltd. The subsidiary will be anchored in Singapore, but will provide the foundation to support Pfanstiehl’s growing customer base throughout the Asia-Pacific region.
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April 2, 2015
Pfanstiehl Establishes European Subsidiary
Pfanstiehl, a leading US-based manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications, has announced the establishment of its European subsidiary, Pfanstiehl GmbH. The subsidiary will be anchored in Switzerland, but will provide the foundation to support Pfanstiehl’s growing customer base throughout Europe, the Middle East, and Africa.
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