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By Your Side for Optimal Patient Outcomes – A Quality Perspective
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
By working by the side of our customers early in the drug development process, we are able to clearly understand what the specific containment and delivery requirements are for their drug product and select the appropriate packaging and delivery systems and materials. These early conversations allow us to align capabilities across the globe to meet high-quality expectations throughout the entire manufacturing process.
For example, we need to consider the particle load throughout the supply chain – including other facilities, materials and processing involved in the production and delivery of the drug product – to ensure that we’re mitigating any additional burden that may exist later in the process that could impact the final quality. West takes an active role in supporting our pharmaceutical partners in this process, working collaboratively to develop a solution for the total supply chain.
In addition, quality standards are incredibly important when it comes to the combination of emerging drug molecules and delivery devices. Previous standards didn’t necessarily take into account the unique containment needs of biologics or other large molecule drugs. Additionally, old standards didn’t address the total drug containment and delivery system, but instead focused on individual components, such as stoppers and vials. It’s a completely different supply chain, and the standards need to be updated to address the needs around current drug molecules and delivery systems as well as future therapeutic offerings.
Working by the side of our customer, we can ensure that patients are always in the forefront of the production process, and that the quality of our manufacturing reflects the need for optimal patient delivery. When we understand better how our products will be used and what’s needed to align the capabilities, we can meet or exceed the quality expectations needed for our customers and ultimately the patient.
In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. While it is convenient to receive treatment at home without having to travel to a healthcare facility, the notion of administering drug injections, or even the sight of needles, can be intimidating to many individuals. The process can be greatly simplified with the use of auto-injectors. These devices typically contain a drug-filled syringe and make the injection procedure more straightforward by semi-automating the process.
West had the opportunity to participate in a Girls Exploring Tomorrow’s Technology (GETT) educational video series in February. GETT began in Chester County, PA in 2001 in response to the under-representation of young women in Science, Technology, Engineering and Math (STEM) fields. GETT is an initiative of the Innovative Technology Action Group (ITAG), a program under the Chester County Economic Development Council, driven by the volunteer efforts of local organizations.
Pharmaceutical manufacturers are faced with numerous challenges to produce, package, and ship products successfully to the patient or care giver. Common concerns for all pharmaceutical manufactures include meeting targeted timelines, guarding against drug shortages, increasing speed to market, and generating revenue. Maximizing operating speeds and minimizing operating down time are critical factors for all stakeholders.
Parenteral drugs that are moisture sensitive are produced in a lyophilized state to protect against product degradation caused by moisture. As a result, when considering the stability and shelf life of lyophilized drugs, the residual drug moisture content is critical. It is also a crucial component in the dossier submitted for regulatory filing, which begs the question: How shall the moisture level in the lyophilized drug product cake be maintained during the drug product’s shelf life?
This year not only marks the 10<sup>th</sup> anniversary of our <strong>West without Borders</strong> tradition, but has added a new dimension to the principle of giving. All four West locations in Germany set out to demonstrate their social commitment while hosting a variety of activities in support of a local not-for-profit organization. Thanks to the great efforts of all involved, we were able to generate the record sum of <strong>€20,426.27.</strong>