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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
It’s spring and West technical experts are out and about visiting and presenting at tradeshows near and far.
West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopoeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).<br /><div> </div>
Glucose monitoring, or measuring the amount of sugar in the blood, is a vital part of everyday care for those suffering from diabetes. Traditional tests require patients to prick their fingers and place a drop of blood on a test strip. The strip is then placed in a glucose meter that reports the results to the patient. While this test is very accurate, it offers a reading for only a single point in time. For patients to get a range of their blood glucose levels, more frequent data is needed at a variety of different times.
The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products<sup>1</sup>. FDA Draft Guidances<sup>2, 3</sup> help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
West recognizes its responsibility to operate with integrity and to proactively identify potential misconduct. We hold ourselves accountable to the highest standards of quality, integrity and respect for our team members, our shareholders, our customers, and the patients we jointly serve.
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