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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.
It’s a brave new world for employers. These days, people want more from their employer than a steady job and a paycheck. Today’s employees yearn to connect with a company that aligns with their values, provides a clear and direct strategy, and gives purpose to their work.
Betse Humphrey
Director, Employee Engagement Global Communications
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
To support customers as they navigate the path from drug product discovery to commercialization, West has undertaken a new, proactive strategy: <em>Integrated Solutions.</em> For almost 100 years, West has been developing technical and regulatory expertise in primary drug packaging, delivery devices, and combination products. That wealth of industry experience is now offered to customers who can employ it for any stage of development (Prescreen and Compatibility, Clinical Phases I / II / III, and Lifecycle Management).
On Friday, May 29, team members from West’s Exton headquarters hosted the 10th annual West without Borders picnic. In keeping with this year’s theme of honoring veterans, Exton team members selected the Travis Manion and No Barriers foundations, which support US veterans and their families, as the beneficiaries of the fundraising efforts.