Pfanstiehl Injectable and HPLE Carbohydrates for Protein Stabilisation and Optimisation
Pfanstiehl is a manufacturer specialising in scale-up development, custom synthesis, and purification of injectable, high-purity low-endotoxin (HPLE) carbohydrates. It also produces highly potent active pharmaceutical ingredients (API), and pharmaceutical intermediates.
The US-based company works with amounts from gram to multi-tonne commercial quantities, serving the pharmaceutical, biotechnology, veterinary, and cosmetics markets with custom carbohydrate synthesis and development. These follow current good manufacturing practices (cGMP) and International Conference on Harmonisation (ICH) guidelines.
High-purity ingredient application to stabilise proteins, mAbs, and vaccines with injectable excipients
Protein stabilisation can be achieved by using Pfanstiehl’s high-purity ingredients (HPI). Trehalose and sucrose can stabilise proteins, lipids, and carbohydrates throughout freeze and formation cycles of remedial treatment. They can also help improve recovery of bioproduction cells and those used in cell therapy.
Applications of this method include for vaccines, stem cell technology, monoclonal antibodies (mAb), and antibody fragments (fAbs). They are also often used in the cryopreservation process. Sucrose is preferred over trehalose in cases where viscosity and solubility are an issue.
In addition, trehalose can be produced for drug delivery, as a stabiliser of vaccines, and as a lyoprotectant.
Manitol is produced by reducing sugar and is often used as a bulking agent in tablets. It can be used to stabilise liquid formulations and vaccines, protecting proteins from reconstitution, denaturation upon lyophilisation, and spray drying. It can also be used as a lycoprotectant. Pfanstiehl’s D-Mannitol is available in packet sizes, including 1kg, 5kg, and 25kg.
Another protein stabilisation product offered by Pfanstiehl is high-quality, pharmaceutical grade maltose. This product can be used in certain countries to stabilise fluids. Other applications include blood fractionation, as a bulking agent, and to prevent protein aggregation in intravenous immunoglobulin (IVIG) solutions.
Optimisation of protein production
Pfanstiehl’s HPLE mannose and galactose play key roles in the optimisation of protein therapeutics bioproduction. Mannose is important in the human metabolism and is critical to ensure the potency, consistency, and yield of therapeutic glycosylation. Pfanstiehl specifically develops these carbohydrates for biopharmaceutical use and the high-quality standards of the industry.
Galactose has an added benefit of mitigating lactate and ammonia formation throughout the optimisation process. This monosaccharide sugar is found in beets, mucilages, and gums. It is used as a modulator in protein bioproduction.
Developing and manufacturing API and HPAPI
Pfanstiehl’s main areas of specialism include carbohydrate chemistry for rare and blocked sugars, advanced intermediates, as well as potent or cytotoxic compounds.
It develops linker-toxins to support ADC manufacture and nucleoside chemistry for generic APIs.
The Special Chemicals Corporation was founded by Carl Pfanstiehl. He began by offering enzymes, high-purity carbohydrates, and amino acids to analytical laboratories and hospitals. By 1930, manufacturer and distributer of dairy supplies Babson Brothers joined, helping with finances and management. The company was renamed Pfanstiehl Chemical Corporation.
The company became a subsidiary of Babson in 1942, operating its dairy sanitary, metallurgical, and fine chemicals divisions. Throughout the late 1940s and into the early 1950s, the company gained new members and began producing biochemical in larger entities. By 1959, the company shifted its focus towards carbohydrates and other organic chemicals.
It was at this point Pfanstiehl significantly expanded its capacity by moving to its current location in Waukegan. Over the next 50 years, the company worked closely with its pharmaceutical and biopharmaceutical clients.
Its current main focus is to synthesise commercial and proprietary compounds. It designs its new facilities, conducts procedures, and trains staff to meet or exceed US Food and Drug Administration (FDA), current good manufacturing practice (cGMP), occupational safety and health administration (OSHA), and international regulatory and multi-compendial standards.
Products and Services
Validated Metal Analysis
Four commonly utilized carbohydrates for ptotein stabilization are Sucrose, Trehalose, Mannitol, and Maltose.
Paradigm Shift Regarding API and Formulation Components
This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limited functionality with the new paradigm, which suggests these components play a significant role in therapeutic stability, quality, potency, immunogenicity, and bioavailability.
Benefits of Trehalose
Products such as monoclonal antibodies (mAb), fusion proteins, peptides, vaccines, antibody drug conjugulates (ADC) and stem cells benefit from the stabilising effects of Trehalose.
Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials
The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component.
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