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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!
Vial adapters are easy to use and pose less risk of needlestick injury than traditional syringe and needle manipulation. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
West's contract manufacturing team has once again reached a record level of support for Temple Street Children’s Hospital and recently presented a check for €18,000 that was raised by employees in 2015.
Employees of The Tech Group Puerto Rico donated $1,000 to Optometry Giving Sight (OGS), an organization dedicated to helping people around the world who are blind or vision impaired. OGS is a global fundraising initiative that specifically targets the prevention of blindness and impaired vision due to uncorrected refractive effort – simply the need for an eye examination and glasses.
Final packaging is often the last process step before a product leaves a factory. Any failure in the process at this point puts the cost of the finished and filled drug at risk, as well as the capacity of the process.<br />
Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require frozen storage due to their fragile nature at ambient temperature, putting unprecedented expectations on the vial-stopper-seal combination to maintain container closure integrity (CCI) during storage at low temperature conditions. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen vial-stopper-seal combination doesn’t maintain a sterile barrier from when the drug is packaged through to administration to the patient. During cooling from ambient temperature to temperatures below -80°C, packaging components such as glass vials, elastomeric closures, and aluminum seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect their ability to maintain CCI, resulting in the formation of transient leaks.