Pfanstiehl

Pfanstiehl is the market leader of high purity / low endotoxin carbohydrates 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

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)
• Peptides
• Stem cells
• Vaccines

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

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 (New)

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).

Pfanstiehl Has Launched

Sodium Succinate (Anhydrous) High Purity/Low Endotoxin, NF

First cGMP and HPLE compendial product to the market supporting the high purity needs of the biopharmaceutical industry.

High Purity Low Endotoxin

cGMP-Produced Made in USA

Extensive Product Characterization Data Available

Maltose

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 (New) 

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

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

Click here for Product Profile Information or Complimentary Samples

Karim Pirani

Director, Business Development

Eastern USA

(978) 831-8858

Karim.Pirani@pfanstiehl.com

Chandra Kelley

Director, Business Development

Western USA

(951) 331-9913

Chandra.Kelley@pfanstiehl.com

Christian Lotz

Director, Business Development

Europe, Middle East, Africa

+41 79 699 94 96

Christian.Lotz@pfanstiehl.com


Jagdish Kuchibhatla

Vice President, Sales & Marketing

Asia Pacific

+65-91076235

Jagdish.Kuchibhatlas@pfanstiehl.com

Customer Service

Global

+847 623-0370

cs@pfanstiehl.com

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