J T Baker brand cGMP-manufactured Polysorbate 20 and Polysorbate 80 now available in high purity and Super Refined grades
Avantor Performance Materials has added a higher purity Super Refined grade of polysorbate products to its portfolio, which the Center Valley, PA, US-based firm says will improve solubilisation and stability in a variety of biopharmaceutical and small-molecule drug formulations.
The new products join Avantor’s J T Baker brand Polysorbate 20 and Polysorbate 80, which are commonly used in pharmaceutical formulations such as parenteral, otic, ophthalmic, oral and topical preparations. They are manufactured under current Good Manufacturing Practices (cGMP) conditions in FDA-registered ISO 9000-certified facilities. They take advantage of a proprietary flash chromatographic process that removes polar and oxidative impurities, such as peroxides and aldehydes, which can degrade active pharmaceutical ingredients.
\'Pharmaceutical manufacturers are increasingly facing challenges to ensure the stability of their formulations and improve the shelf life of their products,\' said Paul Smaltz, Avantor Executive Vice President for Pharmaceuticals. \'We’re pleased to offer these additional options in our polysorbate products so customers can match the right level of purity to their formulation needs.\'
The surface activity of polysorbates helps to stabilise proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilisation while enhancing the stability of emulsions.
J T Baker polysorbates are vegetable-based, with a non-peanut origin, providing low endotoxin and other impurities, which is critical for the formulation of biopharmaceuticals.
The new Super Refined polysorbates are available in bottle sizes ranging from 200ml up to 4 litres, and are packaged under nitrogen to ensure premium product integrity.