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Scientific Insight Enables Risk Mitigation: Why West is By our Customers’ Side
As regulations increase across the pharmaceutical industry, reliable scientific evidence is needed to support the decisions being made during the drug development process in order to achieve the safe delivery of medicines to patients.
Recent regulations around issues such as particulate and heavy metals, require a strong understanding of the testing and analysis to move drug products to the market.
Collaboration with strategic suppliers is critical to managing issues associated with bringing a sensitive drug molecule to market. By supporting our customers from molecule to market, West works to build a close partnership that can provide the scientific analysis, data and regulatory support needed to mitigate risk, speed drug development, and get drug products to market to support patient health.
No matter what challenges our customers face during the drug product life-cycle, chances are West has faced them before. With nearly a century of industry leading experience, West may already have the answers you need, and if not, we can develop a scientific approach to find what you’re looking for. Working together, we can address issues quickly and effectively, helping to mitigate risks as early as possible in the development process by helping customers navigate regulatory and technical challenges.
To learn more about how West can help, check out our video here on our Integrated Solutions Program page.#WestByYourSide
West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.
West's Applied Research Team will be presenting two scientific posters at the upcoming International Society for Cell and Gene Therapy 2021 New Orleans Annual Meeting taking place online May 26 – 28, 2021.
At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled <a href="-/media/8181C68A2AE940A2BB0FC816E642391A.ashx">Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle</a>. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.<br />
Container systems must protect parenteral drug products through the entire shelf life. To accomplish this, container components (vial, elastomer stopper, and metal seal) must fit together well, and maintain an impervious seal. In a sealed system, elastomers are under compression, and it is well known that under compression they undergo relaxation. This raises the question whether such relaxation will affect the seal performance over time, and thus container closure integrity (CCI).
Moore’s Law states that the number of transistors in a circuit doubles approximately every two years. This once lofty prediction proved accurate and has been the basis for long-term planning, not just for the semiconductor industry, but research and development in general.