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cGMP NAD Galactose

Reinvigorated Pfanstiehl Launches Its New cGMP-Produced, Non-Animal Derived Galactose, Targeting Upstream Bioprocessing Applications.
March 24, 2014

Since shedding Ferro in April of 2013, the newly independent Pfanstiehl has been carefully considering its options to bring a new generation of formulation and bioprocessing solutions to its biopharma clients worldwide. Known for nearly a century for its first in class carbohydrate chemistry expertise, Pfanstiehl has built a reputation on high quality, cGMP-produced excipients and highly potent APIs at its Waukegan, Illinois headquarters. Cynthia Kerker, Pfanstiehl’s President, states, “We have a renewed focus on delivering solutions to the challenges brought to us by our customers. We believe that by smartly expanding our High Purity excipients portfolio, we will enable our clients to achieve their formulation goals without sacrificing quality.”

Today, Pfanstiehl is focused on building on its rich heritage by investing in new product development and expanded capacity to meet the growing demand for highly consistent, pure, and functional solutions for process developers and formulators. As the industry undergoes the transformation from small molecule therapeutics to biologics, scientists are being challenged with the often daunting task of screening an endless array of media components and excipients from across the globe, while trying to gain an understanding of the supply chain and regulatory complexities that exist for those materials. All too often, they are finding that resources have been squandered and time lost due to inconsistent quality or compliance limitations at the source. The global regulatory environment, now more than ever, dictates that these critical materials not only function properly, but are of cGMP quality, are from a reputable source, and are of non-animal origin.

It follows that Pfanstiehl’s first product launch of 2014 is its new high-purity, low endotoxin, non-animal-derived Galactose, manufactured in the US, under strict cGMP, ICH Q7 compliant conditions. “Clients have already observed the benefits of Galactose as a cell culture media component” says Dr. Christopher Wilcox, VP, Business Development at Pfanstiehl. “Galactose has been demonstrated to reduce lactate and ammonia build up, thereby enhancing overall culture performance and yield. With a high purity, GMP-produced, animal free option now available, Galactose is likely to gain even more recognition as a critical component of media for production of novel protein therapeutics and biosimilars”.

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For more information about Galactose and other Pure Solutions

Galactose (NAD)

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 (HPLE) Galactose (NAD) 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 (NAD) in bioproduction include but are not limited to:
• Improved Regulatory Compliance
• Reduced Lactate & Ammonia Production
• Increased Target Protein Production
• Clean & Consistent Media Impurity Profile

Pfanstiehl Brand Galactose is available as USP/NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia).

Product Description Product Code
D-Galactose, Plant Derived, High Purity Low Endotoxin, USP/NF, EP G-126-1

 

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

Galactose

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 (HPLE) 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).

Product Description Product Code
D-Galactose, Lactose Derived, High Purity (Low Endotoxin), USP/NF, EP G-125-1
D-Galactose (Low Endotoxin) G-105-1
D-Galactose, (Low Endotoxin), Bioburden Tested G-105-6
D-Galactose, High Purity G-106

 

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

_ppc contact

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Pfanstiehl, Inc.
1219 Glen Rock Avenue
Waukegan, IL 60085-0439

Phone: +1 847-623-0370
Fax: +1 847-623-9173

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Our key areas of expertise include:

CDMO Potent, Proprietary, and Generic APIs
High Purity, Low-Endotoxin Carbohydrates

  • Galactose (Non-animal)
  • Trehalose
  • Sucrose
  • Mannitol
  • Maltose
  • MannoseSodium Gluconate

Large Volume Parenterals

  • Ammonium Lactate
  • Sodium Lactate

Current Generic APIs

  • Cytarabine
  • Steptozotocin

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Products

API Contract Development & ManufacturingContract Manufacturing Solutions_small

Pfanstiehl has been developing and manufacturing Active Pharmaceutical Ingredients for over 30 years.

SKU
Description
CAS No.
C-145Cytarabine, U.S.P.147-94-4
S-119Streptozotocin18883-66-4

 

 

cGMP-Produced Formulation ComponentsPrint

Pfanstiehl offers High Purity Ingredients manufactured under ICH Q7 cGMP conditions serving a multitude of industries with varying specifications.

SKU
Description
CAS No.
A-152Ammonium Lactate515-98-0
A-152-1Ammonium Lactate (Pharmaceutical Grade)515-98-0
D-112Dextrose, USP (Anhydrous)50-99-77
D-112-1Dextrose, ACS (Anhydrous)50-99-77
F-101Fructose, USP57-48-7
F-104-1L-Fucose2438-80-4
G-105-1D-Galactose, (Low Endotoxin)59-23-4
G-105-3D-Galactose, Plant Derived59-23-4
G-105-6D-Galactose, (Low Endotoxin), Bioburden Tested59-23-4
G-106D-Galactose, High Purity59-23-4
G-110D-Glucoheptono-l 4-lactone60046-25-5
G-125-1D-Galactose, High Purity (Low Endotoxin), USP/NF, EP, Lactose-Derived59-23-4
G-126-1D-Galactose, High Purity (Low Endotoxin), USP/NF, EP, Plant-Derived59-23-4
M-105Maltose Monohydrate6363-53-7
M-109-6D-Mannitol, High Purity (Low Endotoxin), USP, EP, JP69-65-8
M-131-1Maltose, High Purity, Hydrate (Low Endotoxin), USP/NF6363-53-7
M-131-2Maltose, High Purity, Hydrate (Low Endotoxin), USP/NF Bioburden Tested6363-53-7
S-108Sodium Gluconate (Low Endotoxin), USP527-07-1
S-110Sodium DL-Lactate Solution 60%, USP72-17-3
S-112Sorbitol, NF50-70-4
S-117Sucrose, NF57-50-1
S-117-1Sucrose, ACS57-50-1
S-124-1-MCSucrose, High Purity, (Low Endotoxin), USP/NF, EP, JP, Cane Derived57-50-1
S-124-1Sucrose, High Purity, (Low Endotoxin), USP/NF, EP, Cane Derived57-50-1
S-124-2-MCSucrose, High Purity, (Low Endotoxin), USP/NF, EP, JP, Beet Derived57-50-1
S-124-3Sucrose High Purity, (Low Endotoxin) USP/NF, EP, Carbon Treated57-50-1
T-104α,α-Trehalose Dihydrate6138-23-4
T-104-4α,α-Trehalose Dihydrate High Purity, (Low Endotoxin), USP/NF, EP6138-23-4