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Finding the perfect home can be a challenge. Upfront research could be the difference between selecting a home with a dry basement, or one with a faulty foundation. And once purchased, failure to address small problems can result in big losses. While making a larger investment upfront may be difficult, it pays off in the long run.
It is the same with drug products. The same upfront research can be applied to drug products and their packaging systems. Drug products need a safe place that meets their specialized needs. Identifying upfront the appropriate elastomer formulation, film/coating, and compatibility E/L profile, is a crucial step in finding the right system. When selecting primary packaging (vial, stopper, and seal), it is important to evaluate the whole system as early as possible.West Ready Pack™ system offers a small, easily accessible, “starter home” encompassing these components. This allows drug product manufacturers to establish critical quality attributes and, in turn, help eliminate challenges later in the drug pipeline journey. So how early is “early” and what steps need to be taken to ensure smoother filing with the FDA?
Selecting the proper containment system by Phase 3 is required. Beginning the search during the Pre-clinical or Phase 1 stage will prove most effective- reducing risk during the remaining phases. Problems such as delamination, insufficient containment, and unknown extractables and leachables are three main reasons to evaluate early. Understanding the possible interactions between your drug and the packaging is crucial.
Quality, regulatory and formulation challenges are easier to manage when considered early and if you are well equipped. Doing all the necessary work upfront, such as investing in proper packaging, will allow you to reduce risk of potentially costly issues. Your early stage decisions on the proper home for your drug product will positively impact the rest of your drug development process, saving you time and providing peace of mind at night.
To find out more about what West can offer you in the early stages of development, visit our website or contact a Technical Customer Service Representative.
<em>The West Ambassador Internship Program is a 10-week program that provides college students with meaningful, practical, real-word experience and the opportunity to learn from and work alongside industry experts.</em>
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.
West and Dublin City University (DCU) in Ireland have formed a 4-year educational partnership that will provide 180 students from socio-economically disadvantaged backgrounds with scholarships and educational opportunities. The partnership with the DCU Access programme features the creation of a new annual €45,000 scholarship fund by West to run for four years.
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