Blogs

West is excited to announce an addition to its NovaPure^® product line — NovaPure 3mL Cartridge components, which include plunger and seal components specifically designed to ensure consistency of delivery for higher-volume injectable drug delivery systems. The components were designed to address specific issues and challenges the pharmaceutical industry faces in bringing innovative injectable drug products to market.

With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).¹ The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.

Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.