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An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
This approach necessarily involves addressing particulate contamination. It is well documented by FDA recalls that particulates can lead to serious issues, such as granulomas, infections, inflammations, and embolisms. Select chapters in the U.S. Pharmacopoeia specifically address particulates.
Control of particulate levels in a biologic is essential, and is dependent upon packaging and delivery components. To support companies, West offers the NovaPure® line of elastomer components, its most advanced line. Both stoppers and plungers have been designed according to Quality-by-Design (QbD) principles, and meet West's highest quality standards. These standards are achieved with a FluroTec™ barrier film on faces contacting drug, tighter dimensional control, vision inspection of every component (with West's Envision™ process), and rigorous standards for both visible and sub-visible particles. NovaPure components are already the first choice for many companies.
To learn more about NovaPure® components, and the benefits they bring to biologics and biosimilars, contact a Technical Customer Support (TCS) representative.
NovaPure®, FluroTec® and Envision™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
Small things sometimes come in large packages. When it comes to pharmaceutical components, small items like stoppers and plungers are often sold in quantities large enough to supply drug products to the world. But sometimes, and in particular during the early stages of drug development, large quantities are just too much of a good thing.
Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
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