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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.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
The West Waterford team partnered with Junior Achievement Ireland (JAI) as their capstone charity of choice in 2023. This partnership gives West the opportunity to give back to communities in the South-East region of Ireland through providing a combination of funding support and volunteers.
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.