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In Vitro Technologies has partnered with Pfanstiehl to bring you high purity ingredients for Protein Stabilization, Liquid Applications, Lyo Applications, Media Optimization, Drug Delivery & Solubilization, Vaccine Formulations, Blood Products, Bulking Agents, Cryopreservation/Cell Banking, Buffers, Lyoprotection, Large Volume Parenterals and Specialty.

Pfanstiehl is a global leader in the manufacture of cGMP-produced, high purity, injectable grade excipients and bioprocessing solutions. The majority of leading biopharma firms trust Pfanstiehl to supply them with critical formulation components for their commercial manufacturing needs.

Pfanstiehl Excipients – High Purity /Low Endotoxin – Low Metals.

For formulations including Biologics, Vaccines, Biosimilars, Cell and Gene Therapies.

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High Purity Ingredients

Sucrose

Categories: Protein StabilizationLiquid ApplicationsLyo ApplicationsMedia OptimizationVaccine FormulationsBlood ProductsCryopreservation/Cell BankingLyoprotection.

p sucrose

Description

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 NF (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.

Product Description

Product Code

CAS Number

Sucrose, NF, EP, JP, ChP High Purity Low Endotoxin – Cane Derived

PFAS1241MC1kg

57-50-1

Sucrose, NF, EP, JP, ChP High Purity Low Endotoxin – Beet Derived

PFAS1242MC1kg

57-50-1

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Trehalose

Categories: Protein StabilizationLiquid ApplicationsLyo ApplicationsVaccine, FormulationsCryopreservation/Cell BankingLyoprotection.

p trehaloseDescription

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 NF (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.

Product Description

Product Code

CAS Number

α,α – Trehalose Dihydrate, High Purity (Low Endotoxin), USP/NF, EP, JP, ChP

PFAT10441kg

6138-23-4

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Galactose

Categories: High Purity IngredientsMedia Optimization.

p galactoseDescription

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 NF (National Formulary) and EP (European Pharmacopoeia).

Product Description

Product Code

CAS Number

D-Galactose, Plant-Derived, High Purity Low Endotoxin

PFAG12621kg

59-23-4

D-Galactose, Plant-Derived, High Purity Low Endotoxin

PFAG12631kg

59-23-4

D-Galactose, Lactose-Derived, High Purity Low Endotoxin

PFAG12511kg

59-23-4

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Arginine

Categories: Protein StabilizationLiquid ApplicationsLyo ApplicationsMedia OptimizationVaccine FormulationsCryopreservation/Cell BankingLyoprotection.

Arginine e1536276138606Description

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).

Product Description

 Product Code

 CAS Number

L-Arginine, High Purity / Low Endotoxin-Low Metals, USP/EP/JP/ChP

PFAA1701kg

74-79-3

Available Package Sizes: 1kg, 5kg, 10kg, 25kg, 50kg

Mannose

Category: Media Optimization.

p mannoseDescription

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

Product Description

Product Code

CAS Number

Mannose, High Purity (Low Endotoxin)

PFAM16411kg

3458-28-4

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Maltose

Categories: Protein StabilizationLiquid ApplicationsBlood ProductsBulking Agents.

maltoseDescription

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.

Product Description

Product Code

CAS Number

Maltose, High Purity, Hydrate (Low Endotoxin), USP/NF

PFAM13211kg

6363-53-7

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Dextrose

p dextroseCategories: High Purity IngredientsMedia OptimizationSpecialty & Technical Grade.

Description

Product Description

Product Code

CAS Number

Dextrose USP (Anhydrous)

PFAD1121kg

50-99-7

Dextrose ACS (Anhydrous)

PFAD11211kg

50-99-7

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Mannitol

Categories: Protein StabilizationLyo Applications.

mannitolDescription

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).

Product Description

Product Code

CAS Number

D-Mannitol, High Purity Low Endotoxin USP, EP, JP, ChP

PFAM10971kg

69-65-8

Available Package Sizes: 1kg, 5kg, 25kg, 50kg

Buffers for Formulation & PH

Sodium Succinate (Anhydrous)

Category: Buffers for Formulation & PH.

pfan1Description

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). 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.

Pfanstiehl Brand High Purity / Low Endotoxin-Low Metal Sodium Succinate (Anhydrous) was developed specifically for biopharmaceutical formulation and commercial manufacturing and produced under full cGMP conditions in the United States to the highest quality and purity standards. Pfanstiehl Brand Sodium Succinate (Anhydrous) is compliant with the USP monograph established in 2017 and available as USP-NF (United States Pharmacopoeia—National Formulary).

 

Product Description

 Product Code

 CAS Number

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

PFAD1601kg

150-90-3

Available Package Sizes: 1kg, 5kg, 10kg, 25kg

Sodium Succinate (Hexahydrate)

Category: Buffers for Formulation & PH.

syringe vial Description

Sodium Succinate hexahydrate is the fully hydrated form of sodium succinate. Sodium Succinate is generally used as a Biopharmaceutical ingredient for pH buffering and final product formulation (e.g. Antibody Drug Conjugates/ADCs). The physical properties of this product make it a suitable tool for use in a Formulation Tool Kit.  Pfanstiehl Brand High Purity / Low Endotoxin-Low Metal Sodium Succinate Hexahydrate was developed specifically for biopharmaceutical formulation and commercial manufacturing and produced under full cGMP conditions in the United States to the highest quality and purity standards.  Pfanstiehl Brand Sodium Succinate Hexahydrate is compliant with the USP monograph established in 2017 and available as USP-NF (United States Pharmacopoeia—National Formulary).

 

Product Description

 Product Code

 CAS Number

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

PFAD1611kg

6106-21-4

Available Package Sizes: 1kg, 5kg, 10kg, 25kg

Speciality

Custom cGMP Solutions

Pfanstiehl can create custom solutions to address your unique high purity, cGMP component requirements. Contact us to discuss collaborative opportunities.

Large Volume Parenterals

Product Code

Product Description

CAS No.

PFAA152

Ammonium Lactate

515-98-0

PFAA1521

Ammonium Lactate (Pharmaceutical Grade)

515-98-0

PFAS108

Sodium Gluconate, USP (Low Endotoxin)

527-07-1

PFAS110

Sodium DL-Lactate Solution 60%, USP

72-17-3


Other Speciality Products including Supplements

Please contact Pfanstiehl Customer Service for these products.

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