Pfanstiehl is the market leader of high purity / low endotoxin bioprocessing components for biologics, biosimilars, vaccines, cell culture media and injectable (liquid and lyophilized) formulations and supplies its products to the leading global biopharmaceutical companies.
Pfanstiehl has manufactured parenteral grade excipients for more than 50 years, and Pfanstiehl’s excipients are critical components in the majority of the top ten global blockbuster biopharmaceutical drugs which have been administered to thousands of patients around the world.
Pfanstiehl’s HPLE Excipient products are known as “best in class” due to their high purity, performance, consistency and quality attributes. For more information about Pfanstiehl and our products and solutions, please contact your business development representative or visit
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 Trehalose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics. It is also widely applied as a key component in cryopreservation/freeze media to stabilize cell membranes and improve the recovery and robustness of cells used for bioproduction and cell therapy.
The stabilizing benefits of trehalose include but are not limited to:
• Monoclonal Antibodies (mAbs)
• Fusion Proteins
• Antibody Fragments (fAbs)
• Stem cells
Pfanstiehl Brand Trehalose is available as USP-NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), and ChP (Chinese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Trehalose (T-104-4) product.
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 Sucrose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics. It is also widely applied as a cryopreservative and media supplement in a variety of cell-based bioprocesses. It is preferred to trehalose in applications where solubility and/or viscosity issues are paramount.
The benefits of sucrose include but are not limited to:
• Monoclonal Antibody (mAbs) stabilization
• Media Supplementation
• Antibody Drug Conjugate (ADC) stabilization
• Peptide stabilization
• Stem cell preservation
• Vaccines stabilization
Pfanstiehl Brand Sucrose is available as USP-NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), and ChP (Chinese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Sucrose (S-124-2-MC) product.
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 in tableting. However, it also has unique chemical properties that enable it to stabilize a wide variety of pharmaceutical preparations, including liquid formulations, as well as protect proteins from denaturation/degradation upon lyophilization, spray drying, and reconstitution.
Pfanstiehl Brand High Purity Low Endotoxin Mannitol was developed specifically for biopharmaceutical use, to the highest quality and purity standards. It has been utilized as a key component to stabilize proteins during formulation, freeze drying, and finish/fill applications.
The various benefits imparted by Mannitol include but are not limited to:
• Enhanced Protein Therapeutic Stability
• Vaccine Stabilization
• Carrier in Lyophilized & Spray Dried Formulations
Pfanstiehl Brand Mannitol is available as USP-NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), and ChP (Chinese Pharmacopoeia).
Sodium Succinate (New)
Sodium Succinate Anhydrous is the disodium salt of succinic acid. Sodium Succinate is generally used as a Biopharmaceutical ingredient for pH buffering and final product formulation e.g. Antibody Drug Conjugates (ADCs).
Pfanstiehl Brand Sodium Succinate Anhydrous is compliant with the USP monograph established in 2017 and available as USP-NF (United States Pharmacopoeia—National Formulary).
Pfanstiehl Brand High Purity Low Endotoxin, Low Metal Sodium Succinate Anhydrous was developed and produced under full cGMP conditions in the United States, specifically for commercial manufacturing of Biopharmaceuticals, to the highest quality and purity standards.
The physical properties of this product make it a suitable tool for use in a Formulation Tool Kit. Sodium Succinate Anhydrous is a white powder with a melting point of more than 400 degrees Celsius, and has a water solubility of more than 100 g/L. It is typically stable at pH 4, 7 and 9 at 50 degrees Celsius for 5 days, and readily biodegradable.
Maltose is a disaccharide consisting of two glucose molecules with an α-1,4 glucosidic bond. Upon injection, it is only requires a minimal amount of insulin, having little impact influence on blood-sugar levels. Hence, it is commonly used to stabilize intravenous IG infusions, among other protein-based formulations.
Pfanstiehl Brand, High Purity Low Endotoxin Maltose is a high quality, pharmaceutical grade maltose that can be used in bioprocessing and parenteral applications. In addition to use in nutritional intravenous fluids in certain countries, it can be also used as an excipient for protein stabilization.
The applications of maltose include but are not limited to:
• Blood Fractionation
• Prevention of Protein Aggregation in IVIG solutions
• Protein stabilization
• Bulking agent
Pfanstiehl Brand Maltose is available as USP-NF (United States Pharmacopoeia—National Formulary). Pfanstiehl also holds a US DMF for Maltose.
Galactose is a monosaccharide sugar of the hexose class that is a constituent of lactose and many polysaccharides. Galactose 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 optimization of protein therapeutics bioproduction.
Pfanstiehl Brand High Purity Low Endotoxin Galactose was developed specifically for biopharmaceutical use, to the highest quality and purity standards. It has been utilized as a key, chemically defined component to optimize protein production while mitigating lactate and ammonia formation.
The various benefits imparted by Galactose in bioproduction include but are not limited to:
• Reduced Lactate & Ammonia Production
• Increased Target Protein Production
• Clean and Consistent Media Impurity Profile
Pfanstiehl Brand Galactose is available as USP/NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia).
Mannose is a C-2 epimer of glucose and a sugar monomer of the aldohexose series of carbohydrates. Mannose is important in human metabolism, particularly in the proper glycosylation of native proteins. It follows that extracellular mannose has been demonstrated to play a critical and ever-increasing role in the optimization of protein therapeutics bioproduction.
Pfanstiehl Brand High Purity Low Endotoxin Mannose was developed specifically for biopharmaceutical use, to the highest quality and purity standards. It has been utilized as a key component to ensure consistency of therapeutic glycosylation, potency, and yield.
The various benefits imparted by Mannose in bioproduction include but are not limited to:
• Enhanced Consistency of Protein Product Quality
• Minimized Need to Troubleshoot Variants
• Clean Media Impurity Profile
L-Arginine is an essential amino acid that is physiologically active in the L-form. The amino acid L-Arginine is frequently used as a solution additive to help stabilize proteins against aggregation, particularly in the process of protein refolding.
Amino acids have been known to exhibit both lyoprotective and cryoprotective effects similar to those of established stabilizers, such as sugars and/or polymers, but they offer a greater range of chemical structures and physicochemical properties. Their ability to prevent protein aggregation in both liquid and solid states, make them an attractive alternative as protein stabilizers for freeze drying. L-Arginine has a chemical structure and physicochemical characteristics which are distinct among amino acids and can provide additional benefits to freeze-dried protein formulations with regard to stability.
Typically known and used as a key component in upstream cell culture, L-Arginine has also been utilized to help prevent aggregation of pharmaceutical formulations containing therapeutic proteins at relatively high concentrations.
Pfanstiehl Brand High Purity, Low Endotoxin & Low Metal Arginine establishes a new quality standard for amino acids, designed specifically for Biopharmaceutical and Pharmaceutical Production.Pfanstiehl Brand Arginine is available as USP (United States Pharmacopoeia), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia) and ChP (Chinese Pharmacopoeia).
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