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Scientific Insights Help Ensure High-Quality Outcomes
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:
system screening
protein adsorption analysis
biologic activities assay
primary structure analysis
protein particles & aggregation testing
protein thermal stability
product-related structure & impurities
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
CCS analysis
components selection/recommendation
process set up, troubleshooting & optimization.
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!
Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal.
The West Generics team recently hosted a virtual panel event featuring experts from pharmaceutical, supply chain and consulting backgrounds to discuss the trends, pressure points and best practices around generics with a goal of shared understanding around a growing market.
Leachables are chemical species that migrate from packaging or other components into the drug product under normal conditions. Request for the leachables data is typically raised on dossier submission and/or during audits.
West's facility in Kearney, NE has been awarded the 2018 Large Business Diversity Employment and Inclusion Award, presented by Nebraska Vocational Rehabilitation (VR). Nebraska VR is an employment program that helps people with disabilities prepare for, find and keep a job while helping businesses recruit, train and retain people with disabilities.<br />
Few topics generate as much interest as the reduction of drug manufacturing end-of-line rejects, which is one of the clearest and easiest ways to reduce waste and maximize operating profit and may help improve patient safety. One of the largest contributing factors to the end-of-line reject rate is the quality of the packaging components selected for the drug product.