We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Your Password has changed! Please login again
Cart
Outdated Browser Detected
Our website has detected that you are using an outdated browser that will prevent you from accessing certain features.
Please use one of the below recommended browsers to improve your browsing experience
When faced with drug shortages or supply chain issues affecting a branded drug product, generic drug manufacturers need to move quickly to help ensure that needed therapies reach the market safely and efficiently. Access to high-quality packaging and delivery components can make a huge difference in ensuring patients receive life-saving medications on schedule.
At West, we work by the side of our generic drug partners to ensure that they have access to components that not only meet the increasing demand for better quality packaging and delivery for generic drug products, but also provide the efficiencies they need to make the move to market fast.
Speed to market is also important for generic customers who may hold a number of Abbreviated New Drug Applications (ANDAs ) and need to move quickly to produce different products in their portfolio, which can be driven by market conditions such as drug shortages where there is a need to respond immediately.
Our AccelTRA® component program provides a robust, efficient platform of components that are compatible with a broad variety of generics molecules and chemicals. This program offers customers the possibility of building a platform of delivery options and packaging for a variety of molecules with a single supply platform.
In addition, West has built a global supply chain network to provide made-to-stock AccelTRA components with extremely fast sampling and delivery lead times. Samples are available with a one-week lead time, and commercial quantities within six weeks.
At West, we’re by your side with excellent technical service that helps customers work through issues and make the move to market fast. We bring the service solutions – including laboratory services, contract manufacturing, and regulatory support for a growing number of proprietary delivery devices – so that customers that need to move fast have the services available to help.Click the links for more information about our AccelTRA program, or our Integrated Solutions (link) program.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require frozen storage due to their fragile nature at ambient temperature, putting unprecedented expectations on the vial-stopper-seal combination to maintain container closure integrity (CCI) during storage at low temperature conditions. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen vial-stopper-seal combination doesn’t maintain a sterile barrier from when the drug is packaged through to administration to the patient. During cooling from ambient temperature to temperatures below -80°C, packaging components such as glass vials, elastomeric closures, and aluminum seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect their ability to maintain CCI, resulting in the formation of transient leaks.
At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. <span></span>Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. <span></span>West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
Amy Kim
Sr. Specialist, Scientific Communications, SA & TS
<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>
When you think of injectable medication, a classic image may include a set of hands holding both a vial and a syringe to withdraw medication prior to injection. Advances in both drug products and self-injection options – including auto-injectors, pens and other self-injection devices – have helped to draw a new picture for injectable delivery.<br />