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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:
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
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.
Vial-based primary packaging systems for sterile drug products must provide protection over shelf life. This requires demonstration of container closure integrity (CCI); this testing should be performed early in the drug product development stage. As we all know, there is not one CCI test method that fits all systems/conditions.
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
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.