Inside the Industry’s New RTU Alliance

What is the story behind the alliance? Why is now the right time for it?
 

The alliance stemmed from the shared recognition that the pharmaceutical industry has not yet fully realized the potential of ready-to-use (RTU) vials and cartridges. There is a growing demand in the industry for greater efficiency, faster production times, and enhanced product quality. RTU technology meets these needs by simplifying the filling process, reducing contamination risks, and improving overall sterility assurance. The technology is proven, regulatory pathways are clear, and the industry's needs align well with what RTU offers.

By working together, we can highlight the benefits of these solutions through our expertise and capabilities, and together, we can better educate the market about the significant operational and cost-saving advantages of RTU solutions.

Ready-to-use vials and cartridges have been available in the pharma industry for some time. What is preventing companies from making the switch?
 

One key factor is the existing investment in traditional in-house fill and finish infrastructure that historically processed bulk drug containment products. Many companies have long relied on these approaches and as they evaluate a switch to RTU technologies, they must consider the costs and operational changes required. Although RTU technologies have evolved and meet rigorous standards, there is still some resistance rooted in the perception that switching requires changing established workflows and procedures.

The biggest gap in understanding is perhaps around how RTU technology can improve operational efficiency and reduce costs. Many companies are unaware that RTU technology has proven its value in streamlining production by eliminating the need for in-house washing, depyrogenation, and sterilization. Additionally, regulatory agencies like the FDA and EMA are well-acquainted with RTU systems and have established clear guidelines for their use. This regulatory clarity makes it easier for companies to integrate RTU technology without facing major approval hurdles.

How does the alliance plan to address the key challenges in the adoption of RTU?
 

We plan to address these challenges by providing education and resources to companies, such as through scientific publications, white papers, workshops, and direct engagement with stakeholders, we can demonstrate how RTU solutions have been successfully implemented, even in large-scale, high-volume production environments. Additionally, the alliance can demonstrate how suppliers are already supporting pharma customers in regulatory compliance by sharing real-world case studies and success stories. We believe conducting these measures will help address the concerns of companies that have yet to adopt the technology.

Each founding member of the alliance brings deep expertise in pharmaceutical packaging and processes. Over the years we have invested to offer customers RTU solutions matching the market trends and requirements, such as increased regulatory requirements or the marketing of high-value drugs which require high quality containment solutions. It needs to be stated, however, that the Alliance for RTU is designed to be an open platform, welcoming other companies along the value chain to advance knowledge and the state of RTU technology.

Looking ahead, what are the alliance's long-term goals for the adoption and evolution of RTU technologies within the pharma industry?
 

Our primary goal is to demonstrate the efficacy and superior performance of RTU solutions. We believe this will create a path for RTU technologies to become the industry-wide standard for aseptic filling operations. Collectively, we will continue to evolve alongside the needs of the pharmaceutical industry. It is our goal to continue contributing to a more efficient, sustainable, and cost-effective supply chain for injectable medicines, benefiting manufacturers, healthcare providers, and patients alike.

How do you see RTU technology evolving in the future?
 

RTU technology is a mature and proven format that has been in use in syringes for more than two decades. As pharma and biotech continue to drive innovation, the natural next step in drug containment is helping customers plan and transition to higher quality RTU technologies for vials and cartridges – suitable for small batches or volumes at scale. We anticipate that RTU technologies will become the gold standard across the industry and the alliance is committed to educating the industry and helping manufacturers make the transition to RTU solutions.