Meet the 2023 FOYA Honorable Mention Winner: Nexus Pharmaceuticals
The 2023 Facility of the Year Awards (FOYA) Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
About the Company: Nexus Pharmaceuticals, LLC specializes in innovative processes to make difficult-to-manufacture injectable drugs easier to use, less labor-intensive, and more streamlined in practice. Founded in 2003 by chemists Mariam S. Darsot and Shahid Ahmed, Nexus has many critical-need injectable mediations in their pipeline, many of which have a history of shortages.
Project: Project Tomorrow Fill/Finish Facility
Solving Supply Chain Issues
Nearly 40% of the generic drugs US citizens take are imported. The COVID-19 pandemic illustrated how supply chain disruptions could prove disastrous when one has an overreliance on offshore sources. Nexus is committed to providing a more stable and reliable supply of sterile injectables – a category that is particularly susceptible to drug shortages – in an array of therapeutic areas, including anesthesia, oncology, cardiovascular, and neurology. Many of the products that Nexus has produced have been on or are on a US drug shortage list.
The Project Tomorrow facility, located in Pleasant Prairie, Wisconsin, was conceived with the idea that medications should be affordable but with the highest quality. The design team created a facility that was right-sized and hyper-efficient. The team focused on the best use of space and utilities, all to reduce the cost of manufacturing and lower the cost of the product. This will translate to affordable healthcare products made here in the US at the highest quality.
Nexus Pharmaceuticals partnered with IPS-Integrated Project Services, LLC (IPS) to design a facility and process design that could allow operations to expand physically in stages over the next ten years. The initial stage, a $85.3 million, 84,000-square foot facility, opened in 2022 with a high-speed manufacturing vial line. Phase 1A of this multiphase, multiyear project features a barrier isolator-based liquid/lyophilized vial filling line. Phase 1B features a barrier isolator-based syringe filling line.
Ultimately, the facility will expand to six manufacturing lines over the next decade in two additional stages, at an estimated total investment of $250 million. The facility currently employs state-of-the-art isolator technology, two vial filling suites, and the capability to produce aseptic, terminally sterilized, and lyophilized products. The heightened rate and production level that the manufacturing suites bring to Nexus allow the company to supply more of its drugs and reduce patient costs.
Why They Won:
Innovative, Flexible, Easily Expandable, Efficient Facility: To meet the shortages in the domestic supply of generic injectables – particularly those identified by the FDA as a critical need – Nexus Pharmaceuticals chose a modular design that can easily expand to add manufacturing lines over the next decade. Meanwhile, individual manufacturing lines are engineered to allow rapid changeover between campaign production runs.
Clever Building Design: While compact, the facility’s structure allows for an expansive set of manufacturing bays for modular cleanroom insertion. The overall structure is configured around workflow and the support of manufacturing line operations, from utility management to the movement of finished products into warehouse freezers.
Room to Expand: While compact, the facility’s structure allows for an expansive set of manufacturing bays for modular cleanroom insertion. The overall structure is configured around workflow and the support of manufacturing line operations, from utility management to the movement of finished products into warehouse freezers.
Facility of the Future Concepts: Nexus Pharmaceuticals does not know when or where shortages of generic or specialty injectables may occur in the future, so it built a facility already prepared for the unknown. The design of Project Tomorrow allows for modular cleanroom manufacturing suites that will adapt to emerging needs as well as the expansion of utilities and all support areas, when required.
Societal and Market Impact: Project Tomorrow was designed to bring about better tomorrows for Americans affected by shortages in critical generic injectable and specialty drugs. The facility will ensure that such drugs may be produced inexpensively and dependably in the United States. Moreover, the project is designed to have a lasting impact in the region through investment and partnerships with local institutions. Once future phases are complete, the entire project will have invested $250 million into the local economy and employed 400 highly-skilled workers.
WANT TO LEARN MORE?
Attend the 2023 Facility of the Year Awards Celebratory Reception and Banquet on 15 October at Mandalay Bay Resort in Las Vegas, Nevada, USA held in conjunction with the 2023 ISPE Annual Meeting & Expo.
NOMINATE YOUR FACILITY FOR THE 2024 FOYA PROGRAM!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2024 FOYA program winner. Applications must be submitted by 4 December 2023.
