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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.
Philanthropy is a cornerstone of our culture at West. It anchors our purpose of standing by the side of our customers to make a difference in our global community.
Manufacturers of sterile drug products have a long history of receiving elastomeric plungers for use in a prefilled syringe in a sterilized, ready-to-use (RU) condition. This trend has more recently evolved to include other container closure components including, glass or plastic vials, aluminum over seals and elastomeric stoppers. When accepting RU components into a new or existing manufacturing process, it is important to consider how sterility assurance of the components will be determined.
The AAPS National Biotechnology Conference is just a week away. West is looking forward to attending this conference in San Diego, CA on May 21-23. This year’s scientific symposia look to be fascinating!
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
Amy Kim
Sr. Specialist, Scientific Communications, SA & TS
Innovation at West is at the cornerstone of enabling both top-line growth and bottom-line results, and IT plays an important supporting role. West views social media, mobility, analytics and cloud computing as game-changers, as well as the biggest opportunity for IT to move quickly to innovate with the business. The consumerization of IT has driven down the cost of deploying technologies, and cloud computing has offered the ability to acquire IT as a service. So when it comes to plug and play, IT can move quickly with the business to innovate.