Aseptic Fill Finish
One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
As one of the only CDMOs that can manage sterile fill, device manufacture and final assembly in a single location, we offer a unique combination of expertise, scale and geographic integration. From small-scale clinical batches to large commercial runs and niche production, we have the flexibility and responsiveness to sharpen, optimize and maximize your project.
Aseptic fill finish: Exceptional by design
Exceptional by design informs every aspect of our approach, allowing us to better service your needs through:
Quality
Benefit from our unwavering commitment to quality, including Annex 1 compliance and DEA Class II-V controlled substance approvals, ensuring your product meets the highest standards.
Scale
Access cGMP space rapidly for projects of any scale, from small clinical batches to large commercial production volumes and niche projects.
Automation
Our strategic implementation of advanced automation enhances engineering controls and optimizes your production process, delivering tangible value and increased efficiency.
Efficiency
Leverage our state-of-the-art technology and unmatched expertise to maintain efficient production timelines and maximize your product's success.
Beyond fill finish: Delivering exceptional value
Our aseptic fill finish capabilities extend beyond technical expertise. We optimize your entire production process, minimizing risk and maximizing efficiency through:
Unmatched injectable integration
Our integrated approach to sterile injectables, spanning formulation through final packaging within our St. Louis facilities, streamlines your supply chain, reduces cycle times, and minimizes environmental impact.
Elevated aseptic standards
With over half a century of experience as a leader in sterile fill finish, we strategically leverage technology at our Bridgeton facility to ensure unparalleled efficiency and compliance, tailoring each process to your precise needs.
Annex 1 compliance
As one of the few facilities globally to achieve complete Annex 1 compliance, we utilize the latest isolator technology, including both traditional glove access and advanced gloveless/robotic options, ensuring the highest standards of sterility assurance.
Automated efficiency
Our automated pre-use post-sterilization integrity testing (PUPSIT) system, integrated into the filling machines, ensures rigorous process controls and minimizes downtime. Each suite operates independently, allowing for concurrent operations and streamlined changeovers to keep your production on schedule.
AI-driven optimization
We leverage artificial intelligence (AI) to analyze processes, enhance operator safety and reduce risks. Our commitment to implementing the latest technology ensures optimal efficiency and the highest standards of patient safety.
Related CDMO solutions
From development to commercial manufacturing and beyond, our CDMO solutions are designed to help your product progress with purpose.