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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Our Integrated Solutions program brings together West’s primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source solution. West can help you Simplify the Journey™ at any stage of drug development. Learn more by visiting our Integrated Solutions Program page or contact a technical representative today for additional support and guidance.
Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:<em>Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems,</em> on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.
At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”
<p><em>Dr. Heike Kofler, Amy Miller, Jennifer Riter<br /></em><em>West Pharmaceutical Services, Inc.</em></p><p>One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.</p>
A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.
With the explosive growth in social media, mobile devices, cloud computing and access to data both internal and external to West (now referred to as Big Data), West IT has been working to ensure that we are able to leverage these transformational trends. In 2012, we updated our IT strategy to allow us to be part of the revolution while making it feel more like an evolution. The initial phase began with investments in cloud technologies – both private and public – to drive down IT operating costs and to enable us to take advantage of software enhancements made by our strategic partners.