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At West, our goal is to partner with customers to mitigate risks of drug/packaging incompatibility, container/device and functional challenges. Although we consider critical quality attributes during development of drug packaging and delivery systems, there can be knowledge gaps of various interfaces based on the specific application of use, such as component-to-container, container-to-device, and container-to-drug.
Formed in 2016, Scientific Insights Lab brings together experts with broad knowledge and experience in polymer materials, surface science, biologic drugs and computational modeling. We help customers understand, select, optimize and improve container closure system targeting specific to their drug product applications and manufacturing process.
Our comprehensive protein testing capabilities include:
We also perform surface analytical and functionality testing capabilities to assess drug impacts on containers over time. Using theoretical prediction and experimental verification, we assist our customers to predict long term container/drug compatibility at the early stage of combination product development.
Finally, we can perform container closure system (CCS) compatibility and optimization testing for high-quality performance. When used in combination with the comprehensive container closure integrity (CCI) testing methods, our experts can serve customers with
By partnering together, West’s experts offer customers the ability to understand the interactions of containers and their new drug products, to provide solutions of container closure systems to mitigate risks down the road in a close, collaborative customer relationship.
Learn more by watching our video above or visiting our featured video channel for additional videos!
#WestByYourSide #SimplifytheJourney
Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulatory agencies in the pharmaceutical field. EMA recognizes this and addresses it with the strategic plan: <em>Regulatory Science to 2025</em> – focused on quality, safety and efficacy of both human and veterinary medicines. The draft of this plan, which was created by the Member States and the European Commission, and comprised input from two workshops with stakeholders, was published in December 2018 for a six-month public consultation.
West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.<br />
West celebrated 40 years of successful operations in Kovin, Serbia during the month of October 2021. The West Kovin manufacturing facility specializes in the manufacturing of stoppers and plungers for disposable syringes.
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