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Today’s business environment demands a seamless and continual transition of digital experience to conduct business and engage various stakeholders in the same way we conduct the rest of our lives outside work. The experience expectation is consistent across devices of choice from phones to tablets to laptops. That’s why West partners with the world’s top pharmaceutical, biotech, device and diagnostic companies to embrace technology that supports the patients they serve with online resources and tools to better manage their health. In turn, we’re looking to support our customers with digital tools to help speed the research and development process of bringing life-saving medicines to patients that need them.
Companies seeking to bring an injectable medicine to market are required to complete an immense amount of research on the medicine itself, but they must also study the containment or device options to help ensure that medicine is delivered safely to the patient. The regulatory hurdles associated with combination therapies that include both the medicine, together with a device, represent a host of additional regulatory requirements.
To support customers, West’s Knowledge Center offers an online repository of scientific and regulatory support content that can help customers get the information they need quickly to manage this regulatory process. West also offers commonly requested, detailed product information, including specifications and drawings, on our entire portfolio of elastomer packaging components, pre-filled syringe solutions and wearable devices. Recently, we added the ability to purchase some of these same products through our online store. All of these services are available across a range of digital platforms, so that customers can easily access this information 24 hours a day, regardless of the device they use.
This is just one of the ways West is working to Simplify the Journey™ for our customers, by making it easier for our customers to do what we consider to be some of life’s most important work—developing innovative new medicines to address unmet medical needs. To learn more watch the above video or visit the West Knowledge center.
#SimplifytheJourney #WestByYourSide
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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.
Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.<sup>1</sup> The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.<sup>2</sup>
The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
Anthony Bucci
Principal Engineer, Scientific Affairs, West Pharmaceutical Services
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.<sup>1-3 </sup><br />PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.<sup>4</sup><br />Several USP chapters describe the measurement of PM, namely: