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Commitment to the safest and most efficient delivery of drug products requires a detailed understanding of the constantly changing regulatory landscape. Recently West presented a webinar series discussing the current regulatory requirements for packaging/delivery components and systems, to support not only customers, but the industry as a whole. Each averaged more than 300 registrants – clearly showing the interest in these areas.
Part 1: Elemental Impurities - testing strategies and world-wide pharmacopoeia requirements that affect quality, safety and efficacy of drug products
Part 2: Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution - holistic strategy to ensure that container closure integrity can be maintained to protect sterility over the shelf-life of drug products
Part 3: Demystifying Product Performance Testing: Strategies to Qualify Combination Products - combination product testing strategy based on risk considerations and guidance from widely-accepted standards
Part 4: Navigating Particle Challenges in Sterile Drugs from Component to Patient - strategy for measurement and management of particles, as one of several factors needed in the effort to deliver safe drug products
Each webinar focused on a West technology thrust area. Through the Integrated Solutions platform, West maintains the expertise and facility to support customers not only in navigating the global regulations, but also in designing and performing the studies needed to demonstrate compliance from development through commercialization and beyond.
For more, contact an Account Manager or Technical Customer Support (TCS) representative.
West team members from our facility in Clearwater, FL recently concluded their 2018 West without Borders* campaign. West without Borders is West’s employee-led fundraising initiative, where each of its more than 50 locations worldwide selects a charity to support, then coordinates fundraising activities to raise donations. <br />
West’s Diane Paskiet, Doug Duriez and Gene Polini are among the authors in the recently published <a href="http://www.crcpress.com/product/isbn/9781841848198?utm_medium=Email&utm_source=ExactTarget&utm_term=&utm_content=http://view.email.taylorandfrancis.com/?j=fec615707d62037e&utm_campaign=HLM33E_Encyc_Pharm_Science"><em><span style="text-decoration: underline;">Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition</span></em></a>.
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
<span style="color: #000000;">Save the dates for West’s 2012 Educational Series. Join us as our subject matter experts present </span><strong>“Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”</strong>
The Herman O. West Scholarship Program provides academic scholarships to children of West employees who have demonstrated exceptional academic and extracurricular achievement, as well as a commitment to serving the community. Established in 1972, the program honors Herman O. West, the founder of West Pharmaceutical Services, Inc. Over the past five years alone, the Foundation has awarded scholarships to 42 students attending 33 different colleges and technical schools. West proudly recognizes talented students from across the U.S., and to date has awarded scholarships to the children of employees from thirteen of its U.S. plants.<br />
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