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Pfanstiehl Launches cGMP-Produced, Parenteral-Grade Mannitol

Pfanstiehl has announced the launch of a high-purity, low-endotoxin and low-metal Mannitol, which is manufactured in the US under strict current good manufacturing practice (cGMP), International Conference on Harmonisation (ICH) Q7 compliant conditions.

Mannitol is a tried and true platform excipient used in a wide range of therapeutic formulations. Mannitol has demonstrated its utility as a stand-alone lyo-protectant or bulking agent, as well as in combination with other high-purity excipients like Trehalose and Sucrose to stabilize a variety of systems including monoclonal antibodies (mAb), antibody drug conjugates (ADC), vaccines and small molecules.

As part of Pfanstiehl’s continual commitment to producing the industry’s highest purity, lowest endotoxin and lowest metals for bioprocessing components, the Mannitol (M-109-7) specification includes ICH Q3D Elemental Impurity Data which is backed by extensive product characterization data. The product specification is also compliant with Chinese Pharmacopeia.

Pfanstiehl’s market-leading specifications for the new Mannitol help to provide product quality and consistency for better support with biopharmaceutical processing requirements.

Commercial material and samples from Pfanstiehl’s cGMP manufactured batches of Mannitol are available now for customer qualification and production, along with a Product Profile.

Pfanstiehl provides high-purity / low-endotoxin / low-metal carbohydrates for biologics, biosimilars, vaccines, cell culture media and injectable (liquid and lyophilized) formulations and supplies its products to nearly all of the leading global biopharmaceutical companies.

Pfanstiehl has manufactured parenteral-grade excipients for more than 50 years, and its excipients are critical formulation components in the majority of the top ten global blockbuster biopharmaceutical drugs, which have been administered to thousands of patients around the world.

The company’s excipients are known as best-in-class due to their high-purity, performance, consistency and quality attributes.

Known for nearly a century for its first-in-class carbohydrate chemistry expertise, Pfanstiehl has built a market leading reputation for supplying high-quality, cGMP-produced excipients from its US headquarters north of Chicago.

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