The expansion enhances our US manufacturing site’s ability to support final assembly, labeling, and secondary packaging of complex drug-device combination products, addressing the growing demand for scalable, high-quality pharmaceutical solutions.
Ensera is delighted to announce the completion of a significant upgrade to our North American manufacturing facility, extending our industry-leading expertise in contract development and manufacturing (CDMO) for medical devices and pharmaceuticals.
The expansion enhances our US manufacturing site’s ability to support final assembly, labeling, and secondary packaging of complex drug-device combination products, addressing the growing demand for scalable, high-quality pharmaceutical solutions. This investment reinforces our commitment to providing world-class pharmaceutical manufacturing services in North America. Having already established a strong track record in Europe’s pharmaceutical and medtech sector over 25 years, we are excited to be able to draw on that expertise and experience to offer equivalent services to North American customers who need flexible, fast, high-quality solutions for the final assembly and secondary packaging of their drug + drug delivery devices.
- Jason Anderson, Chief Executive OfficerSpecialist capabilities to support pharmaceutical innovators and their fill-finish partners
The key enhancements to our FDA-registered US manufacturing site, which include three new Pharma Suites and significant cold storage capacity, enable our customers to deliver their combination drug-device products to the US market at speed as part of their balanced global supply chain strategy:
- Final assembly, labeling and secondary packaging for vials, auto-injectors, and prefilled syringes, with primary packaged drug handling capabilities
- Serialization and aggregation, ensuring compliance with global track-and-trace regulations
- Optimized cold storage, designed to minimize time out of refrigeration (TOR) and ensure product integrity
These capabilities – underpinned by internationally-recognized regulations and quality standards – make Ensera a key partner for pharmaceutical manufacturers and fill-finish specialists seeking a streamlined, seamless, GMP-compliant transition to final assembly and secondary packaging for commercial distribution.
Addressing a growing market interest in customized volumes and reshoring
As pharmaceutical companies continue to explore viable options for reshoring manufacturing operations to North America, the expanded site provides a local, compliant and scalable solution for drug-device combination product assembly and secondary packaging, supporting supply chain resilience and the growing need for high-quality, domestic manufacturing capacity.
We are seeing increasing interest from pharmaceutical companies based in North America for fast, scalable solutions that accommodate small to medium volumes or batch sizes for purposes such as pre-commercial validation, clinical trials, and early-stage commercialization. Our expanded capacity and upgraded infrastructure now allow us to tailor solutions to the specific needs of North American customers, with customized assembly lines, flexible manual-to-automated processes, and scalable cold storage capacity.
- Mathew Ninan, Site DirectorFuture growth and expansion
The expansion of our US manufacturing site is just the beginning. Ensera is committed to further investment that enables us to provide much valued continuity to customers as they scale:
- Additional cold storage, warehouse space, and cleanrooms as demand grows
- New automation and labeling technologies to enhance efficiency and scalability
- Expanding our partnerships in Europe and North America to bring innovative pharmaceutical solutions to a global customer base
The upgraded US manufacturing site positions us to meet the increasing demand for small to medium volume pharmaceutical assembly, labeling, and secondary packaging. We are excited to provide scalable solutions that support our customers’ growth in this evolving market.
- Scott Kellogg, VP Pharmaceutical Solutions, North AmericaThis article has been updated since original publication to reflect SteriPack’s new trading name of Ensera.
