Since 1919, Pfanstiehl has been manufacturing the highest quality cGMP Carbohydrates, Amino Acids, and Buffer components in their cGMP ICH-Q7 manufacturing facility in Waukegan, Illinois.
Pfanstiehl provides a range of six high-purity, low-endotoxin, low-metals (HPLE-LM™) carbohydrates of the highest quality suitable for Parenteral Excipient use in injectable biologics and vaccines.
Pfanstiehl’s HPLE-LM carbohydrates include:
- Sucrose
- Trehalose
- D-Galactose
- Maltose
- Mannose
- D-Mannitol
Sucrose NF EP JP ChP cGMP Injectable Excipient-Grade
Pfanstiehl’s HPLE-LM sucrose can be used to stabilise proteins, lipids and carbohydrates during the formulation and freeze/thaw life cycle of a pharmaceutical product. It can also be applied as a cryopreservative and media supplement in numerous cell-based bioprocesses.
Pfanstiehl sucrose offers a range of benefits for biologic protein stabilisation and cryopreservation, including protein and antibody stabilisation, vaccine stability, lipid stabilisation, cryopreservation, and the preservation of stem cells in cell therapy.
https://pfanstiehl.com/en/high-purity-ingredients/sucrose/
Trehalose Dihydrate NF EP JP ChP cGMP Injectable Excipient-Grade
The non-reducing disaccharide Trehalose Dihydrate is made up of two glucose molecules linked by an α,α–1,1 bond. The compound has become widely used in biologic stabilisation applications because of its unique cryopreservative properties.
Pfanstiehl’s Trehalose dihydrate offers various benefits for preserving monoclonal antibodies, fusion proteins, vaccines and stem cells. These include cellular protection, protein stabilisation, prevention of freeze-thaw damage, improved viability and functionality, and enhanced long-term storage.
https://pfanstiehl.com/en/high-purity-ingredients/trehalose/
D-Galactose NF EP cGMP Injectable Excipient-Grade
D-Galactose is a six-carbon sugar that is related closely to glucose and serves as a fundamental component of various glycolipids and glycoproteins. It has become widely used in bioprocessing because of its unique metabolic effects and impact on cell culture conditions.
Pfanstiehl’s D-Galactose addresses the accumulation of lactate and the production of ammonia, both of which can inhibit protein production. The excipient was developed specifically for biopharmaceutical manufacturing and is produced under full ICH-Q7 cGMP conditions in the US to the highest standards of quality and purity.
https://pfanstiehl.com/en/high-purity-ingredients/galactose/
Maltose Monohydrate NF JP ChP cGMP Injectable Excipient-Grade
Maltose monohydrate is a disaccharide sugar made up of two glucose molecules joined together by an α(1→4) glycosidic bond. The carbohydrate is commonly found in various food sources, including malted grains such as barley, and is used frequently in the food industry as a sweetener and flavour enhancer. Within medicine, maltose has found use in stabilising infusions, blood fractionation, and preventing protein aggregation in intravenous immunoglobulin (IVIG) solutions.
One key benefit of maltose is its ability to act as a stabilising agent in infusions, which involve the administration of fluids or drugs directly into the bloodstream. Maltose’s chemical properties help maintain the stability of certain drugs and compounds during infusion; its use in infusion solutions helps protect therapeutic agents from degradation or denaturation, ensuring that the patient receives the desired effects of the treatment.
Pfanstiehl’s maltose monohydrate stabilises proteins in blood fractionation, helping to maintain the integrity of blood components and ensure they can be safely stored and administered, while preventing protein aggregation in IVIG products, which can reduce their efficacy and cause other adverse effects.
https://pfanstiehl.com/en/high-purity-ingredients/maltose/
Mannose cGMP Injectable Excipient-Grade
A C-2 epimer of glucose and a sugar monomer of the aldohexose series of carbohydrates, mannose plays a vital role in human metabolism, particularly in the proper glycosylation of native proteins. During pharmaceutical protein production, Pfanstiehl’s high-purity, low-endotoxin mannose is integral in optimising and ensuring the consistency of glycosylation, potency and yield.
Pfanstiehl mannose offers a range of benefits for upstream biologics protein production, including glycosylation consistency, potency enhancement, yield optimisation, consistency in bioprocessing, and cell line engineering.
https://pfanstiehl.com/en/high-purity-ingredients/mannose/
D-Mannitol USP EP BP JP ChP cGMP Injectable Excipient-Grade
D-Mannitol is a sugar alcohol commonly used in the pharmaceutical and food industries; it takes the form of a white, crystalline powder that is naturally occurring and can be found in fruits, vegetables and certain plants. Because of its chemical properties, D-Mannitol is often used as an excipient in biologics and other pharmaceutical formulations.
The benefits offered by Pfanstiehl’s HPLE-LM D-Mannitol excipient include:
- Protein stabilisation
- Cryoprotectant and lyoprotectant
- Osmotic agent
- Bulking agent
- Solubility and compatibility
- Safety and tolerability
Pfanstiehl’s HPLE-LM Mannitol was developed specifically for biopharmaceutical use and is produced under full cGMP conditions in the United States to the highest quality and purity standards. Our stringent quality systems and manufacturing specifications guarantee that the product is of the highest quality and consistency from batch to batch and the safest product available for use in your manufacturing or research application.
https://pfanstiehl.com/en/high-purity-ingredients/mannitol/
Glucose (Dextrose) USP EP BP JP ChP cGMP Injectable Excipient-Grade
Glucose is a simple sugar and a key carbohydrate in biology. It is a monosaccharide with the molecular formula C₆H₁₂O₆ and is one of the primary sources of energy for living organisms. Glucose is essential for cellular respiration and is a fundamental building block for various complex carbohydrates and biomolecules.
In the context of biologic production, particularly in upstream processes involving the cultivation of cells to produce proteins, glucose serves as a primary feed component. Its role as a feed is crucial for optimising cell growth, metabolism, and the production of high-quality biologic products.
Key Roles of Glucose in Biologic Production
Primary Energy Source:
- ATP Production: Glucose is metabolised through glycolysis, where it is converted into pyruvate while generating ATP, the energy currency of the cell. This energy is essential for various cellular processes, including protein synthesis and cell maintenance.
- NADH Production: In addition to ATP, glycolysis produces NADH, which is used in oxidative phosphorylation to generate further ATP, enhancing the energy supply for high-yield protein production.
Carbon Source:
- Building Block for Biomolecules: Glucose provides carbon skeletons necessary for the biosynthesis of amino acids, nucleotides, lipids, and other essential biomolecules required for cell growth and protein expression.
- Precursor for Polysaccharides: It is a precursor for polysaccharides like glycogen, which cells use as energy storage molecules.
Feed Strategy in Bioprocesses:
- Fed-Batch Cultivation: Glucose is often added in a controlled manner in fed-batch processes to maintain optimal concentrations. This helps avoid depletion, which could lead to reduced cell growth and productivity.
- Reduced Byproduct Formation: Controlled glucose feeding minimises the production of inhibitory byproducts like lactate and acetate, which can accumulate if glucose is present in excess.
https://pfanstiehl.com/en/high-purity-ingredients/glucose-dextrose-usp-ep-bp-jp-chp/