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West Celebrates the One-Year Anniversary of Integrated Solutions
West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.
As injectable medicines have evolved, customers have expressed a need for partners that can offer a more holistic approach encompassing the entire lifecycle of an injectable medicine, from early clinical development to commercialization. The Integrated Solutions initiative from West, now celebrating its one-year anniversary, does exactly that, bringing together West’s primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source solution.
A New Approach for All Customers
The Integrated Solutions initiative elevates West’s role as a partner and collaborator. Our goal is to complement, not duplicate, the functional capabilities of our customers. This enables them to focus on their core competencies while relying on West for services they may not have or plan to have inhouse. As such, with Integrated Solutions in place, we can offer something to every customer, regardless of their size or where their products sit in the development lifecycle.
According to Jennifer Riter, Senior Director, Analytical Services, “We always knew smaller pharma companies could benefit from this type of bundled solution because they simply don’t have the internal resources to accommodate the full range of services West offers. But we were excited to learn how many larger companies were willing, even eager, to engage us in conversations about how we could help.”
The willingness of customers to engage about an Integrated Solutions approach is directly related to the changes and challenges taking place across the industry. “There are a number of trends driving drug and device manufacturing,” Riter points out. “The continued focus on combination products, as well as many pipelines containing complex molecules, are just a few examples.” As companies struggle to respond to these drivers, they face gaps in experience and knowledge. “Integrated Solutions affords West the opportunity to fill these gaps, to leverage the expertise we’ve acquired over nearly 100 years of manufacturing containers, closures and delivery devices for injectable medicines.”
The Journey Continues
Integrated Solutions is a year old, but in reality, West has been offering many of these services independently to customers for over 20 years. Formalizing the name and providing more structure to the program allows us to truly share with our customers what we have learned and how this knowledge can help address our customer’s needs and challenges.
Looking forward, Integrated Solutions will continue to evolve based on industry needs and challenges. As it does, one thing is certain: West is committed to the program because an integrated, comprehensive approach is required for the rapidly changing pharmaceutical landscape.
As Riter points out, “Ultimately, Integrated Solutions is about bringing together the right drugs, devices, and services needed to ensure the best overall patient experience. But the complexities involved to deliver that ultimate experience are significant. It takes collaboration — between manufacturers and external providers like West — and an interconnected suite of services to ensure a product makes it to the market and is used by the people who need it.”
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
West’s Waterford, Ireland site recently partnered with CALMAST which is Waterford Institute of Technology’s (WIT) STEM (Science, Technology, Engineering and Math) engagement hub that was established in 2003 to drive more awareness of STEM, building on the work of secondary schools in the south east region of Ireland.
Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
At West, we actively foster an inclusive and collaborative culture for our team members where different views and perspectives are welcomed and valued. We are convinced that this approach brings forth innovation, learning and growth for our team members on a global basis.
To promote patient safety and the stability and efficacy of protein-based drugs, including mAbs, it is important to store the drugs in compatible container and delivery systems. From the time of storage until the drug reaches the patient, the protein interacts with the surfaces of these systems, which can impact the drug’s stability. The drug also can be affected by the various mechanical stresses and elevated temperatures to which it may be exposed during shipping, handling, and delivery.