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Moore’s Law states that the number of transistors in a circuit doubles approximately every two years. This once lofty prediction proved accurate and has been the basis for long-term planning, not just for the semiconductor industry, but research and development in general.
Much like semiconductor circuits, advancements in scientific discoveries in the pharmaceutical industry have paved the way for explosive growth in biologic drug development. Pharmaceutical drug products, specifically biologics, are not a new concept. However the advancement of monoclonal antibodies and protein therapies are prompting manufacturers to examine the impact of packaging material selection in product development. With this knowledge in hand, manufacturers are thinking more about the significance of the entire container closure system and the important role it plays in delivering effective therapies to patients.
Pharmaceutical packaging and regulatory changes are responding to the rapid growth of biologics in the marketplace. A clear path of communication between the innovator and the packaging industry needs to be established to ensure the appropriate components are recommended. Biologic drugs are more sensitive to extractables, particulate, etc., which may alter the active pharmaceutical ingredient (API) of the drug. Thus, packagers must consider how container closure systems, and the materials used in their construction, can impact the quality of the biologic products they hold.
Change…adapt…adjust. All are synonymous with being reactive. Any advancement in the pharmaceutical industry triggers a cascading response for packaging, governance, and all other industries directly linked to a drug. If testing methods and legacy packaging standards are “grandfathered” without considering more modern, innovative standards for each product or delivery system, this could be problematic. So how can we reverse the trend of being reactive to becoming more proactive?
West’s NovaPure® product line has been designed using Quality by Design (QbD) principles to help maintain drug purity and efficacy and mitigate risk to the patient. High-value NovaPure components use our most modern elastomeric formulations with Flurotec® barrier film to minimize compatibility issues with drug products. To learn more about the proactive strides West is making in the packaging industry, contact Technical Customer Support.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
<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>
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.
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.
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