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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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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

Trehalose: A Powerful Excipient

Trehalose: A Powerful Excipient in the Formulation Toolbox
Ben Nelson, PhD, Chris Wilcox


Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α,α–1,1 glycosidic bond. In the pharmaceutical industry, products which benefit from the stabilizing effects of trehalose include, but are not limited to: monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), fusion proteins, peptides, stem cells, and vaccines. Table 1 is a brief list of drugs which include trehalose as a component of their formulations.

 

Table 1: Drugs Formulated with Trehalose
Drug Manufacturer API Class Formulation Type
Adcetris Seattle Genetics ADC Lyophilized Powder
Avastin Genentech/Roche mAb Solution
Blincyto Amgen Bispecific mAb Lyophilized Powder
Gazyva Genentech/Roche mAb Solution
Herceptin Genentech/Roche mAb Lyophilized Powder
Lucentis Genentech/Roche mAb Solution
Rituxan Genentech/Roche mAb Solution

 

Many of the stabilizing effects of trehalose are derived from its unique properties. The glass transition temperature (Tg) is between 110 and 120°C, which is the highest of the disaccharides. Formulations lyophilized in a glassy amorphous matrix of trehalose can be stored at higher temperatures without concern of negative consequences associated with molecular mobility, since molecular mobility is negligible upon storage 50°C below the Tg of the amorphous matrix. Primary drying during lyophilization should be below the freeze concentration glass transition temperature (Tg’) to prevent cake collapse. In comparison to sucrose, the Tg’ of trehalose is about 3°C higher, translating to an ~13% reduction in primary drying time for every 1°C difference in Tg’. Trehalose itself is intrinsically stable and is not susceptible to breakdown to reducing sugars, since the free energy of the glycosidic bond is 99% of trehalose remains compared to ~0% sucrose remaining in the same conditions.

The quality of excipients used should also be of high importance to the formulator since the use of products known to be of the highest purity can mitigate risk from bench top development through commercialization of therapeutics. There are different grades of trehalose available on the market. Ongoing Pfanstiehl studies have demonstrated that Pfanstiehl’s trehalose contains lower levels of impurities and endotoxins than other marketed brands by factors of 5 and 12 respectively. Details can be shared upon request.

Stabilization of proteins is best taken on a case by case basis. Proteins that do not vary significantly in primary structure can vary drastically in secondary and tertiary structure, and reactivity to their environment. Formulation components that work well for one system may not work for a similar system. Therefore, formulation scientists must use all of the tools they have at their disposal. Despite being less ubiquitous in the pharmaceutical industry when compared to other excipients such as sucrose and mannitol, trehalose should not be overlooked as a powerful tool for drug product stabilization in both liquid and lyophilized drug product preparations.

Known for nearly a century for its first-in-class carbohydrate chemistry expertise, Pfanstiehl has built a reputation for high quality, cGMP-produced, parenteral grade excipients (i.e. trehalose, sucrose, mannitol, galactose, mannose, sorbitol, maltose, ribose) and for highly potent APIs at its US headquarters north of Chicago.

See this exclusive online content on Drug Development & Delivery.

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Pfanstiehl GmbH

Pfanstiehl Establishes European Subsidary.
April 2, 2015

Pfanstiehl, a leading US-based manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications, has announced the establishment of its European subsidiary, Pfanstiehl GmbH. The subsidiary will be anchored in Switzerland, but will provide the foundation to support Pfanstiehl’s growing customer base throughout Europe, the Middle East, and Africa.

Pfanstiehl GmbH will offer the same tried and true, platform-enabling protein stabilizers, lyoprotectants, cell culture media components, and solubilizers as Pfanstiehl, Inc. Such technologies include Trehalose, Sucrose, Mannitol, Sorbitol, Maltose, Galactose, Mannose, and Cyclodextrins.

 


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