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At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
West’s Global Technical Customer Support (TCS) Team is key to this effort – focusing on biopharmaceutical industry needs and partnering with customers throughout the process of selecting and qualifying primary packaging solutions and drug delivery systems. This includes a sound understanding of both the packaging requirements defined by the drug product and the regulatory standards. TCS also provides technical information and scientific data on West and Daikyo products, and facilitates interaction with other West services, e.g. West Analytical Services, to reduce drug product time to market.
Additionally, TCS is active in the biopharmaceutical industry, e.g., participation in industry groups, attending conferences and exhibitions, and delivering technical reports and presentations. This enables TCS to be constantly aware of the latest trends.
Broad technical knowledge, understanding of industry needs, and service excellence ensure that West TCS remains the scientific destination for customers.
Contact a Technical Customer Support representative today to see how West can support you bringing safe, effective drug products to the market.
At West, we have adopted the philosophy that there are no IT projects, only business projects. Even business projects with a high dependence on IT are still business projects that require a business case with a measurable return on the investment. During the past year, West has been working to develop a unified project and portfolio management process. The initiative’s main goal is to ensure that we derive the full value from all business investments, including those that require IT enablement.
Focus on extractables and leachables (E&L) from packaging and delivery systems began in the mid-1990s but, since then, regulatory agencies have become more educated, and expectations of the pharmaceutical industry have increased. Examples of updated recommendations include USP<1663> and <1664> and injectable drug recommendations from Product Quality Research Institute (PQRI). Complex drug product formulations have become more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and drug product. <!--1664--><!--1663-->
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?”
With the help of the FDA’s expedited programs for approval, a new wave of high-value biologic drugs is on the rise in the pharma industry.1 These drugs require cryogenic storage (-80oC to -180oC) to maintain stability. This presents a new challenge: how to measure and demonstrate container closure integrity (CCI) of storage and delivery systems at such low temperatures.<br />