Pfanstiehl – High Purity Ingredients

 

Pfanstiehl - High purity ingredients

Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities.  We serve such markets as pharmaceutical, biotechnology, veterinary and cosmetics.  With over 50 years experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.

 

Our key product technologies:

  • High Potency Substance manufacturing in a certified development and commercial scale multi-purpose containment chemistry manufacturing facility
  • High-purity, low-endotoxin carbohydrates
  • Blocked sugars and derivatives
  • Modified carbohydrates, polysaccharides and oligosaccharides
  • Custom di-and tri-saccharides / complex carbohydrates
  • Sugar acids, esters, alcohols, lactones and salts
  • Injectable Grade Lactate salt solutions

Trehalose

Trehalose for Protein Stabilization, Liquid Applications, Lyo Applications, Vaccine Formulations, Cryopreservation/Cell Banking, Lyoprotection

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) and JP (Japanese Pharmacopoeia) and ChP (Chinese Pharmacopoeia).Pfanstiehl also holds a US DMF for the Trehalose (T-104-4) product.

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Sucrose

Sucrose for Protein Stabilization, Liquid Applications, Lyo Applications, Media Optimization, Vaccine Formulations, Blood Products, Cryopreservation/Cell Banking, Lyoprotection

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) and JP (Japanese Pharmacopoeia) and ChP (Chinese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Sucrose (S-124-2-MC) product.
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Mannitol

Mannitol for Protein Stabilization, Lyo Applications.

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).

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Further High Purity Ingredients

 

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