Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner
Eli Lilly and Company is the 2019 ISPE Facility of the Year Category Winner for Process Innovation for their IE2 Small Volume Continuous Facility located in Kinsale, County Cork, Ireland.
Projects selected in the Process Innovation category demonstrate application of novel process manufacturing techniques on existing and new facilities, including fundamental scientific processing approaches and related applied science-based solutions to existing and new challenges.
Lilly, founded more than a century ago, is a global healthcare leader that unites caring with discovery to make life better for people around the world. As a company, they are committed to creating high-quality medicines that meet real needs. In 2015, Lilly approved a project for the design and installation of a multi-product GMP small volume continuous facility in an existing Lilly manufacturing building. The objective was to enable the manufacturing of multiple steps of a drug substance process simultaneously to reduce the time required to bring medicine to the patient.
Continuous manufacturing (CM) has proven its benefits of improved quality, safety and manufacturability in drug product oral solid dose and Lilly has been recognized as an industry leader in this transition. Continuous manufacturing has more recently expanded into drug substance manufacturing using limited CM technologies in place of a single batch operation. In these cases, the economic drivers to install a fit-for-use plant can be clearly articulated. Lilly now takes a significant leap to a multi-product CM facility designed to manufacture entire process steps continuously for the rapid delivery of API to meet patient needs. This new GMP facility at the Lilly manufacturing site in Kinsale, Ireland now supports development, clinical and commercial manufacturing of new chemical entities for lower-volume potent products.
The ultimate goal for small volume continuous (SVC) is to reduce the time it takes to develop and manufacture a process so that life-changing medicines are produced as quickly as possible for patients who need them. SVC achieves this goal by the flexible, modular nature of the equipment and by telescoping multiple steps. The SVC facility using continuous processing equipment can manufacture multiple steps of a process simultaneously. This means the facility can produce drug substance in about a week after starting to feed and consume the GMP starting materials in the earlier processing steps. This will give an unprecedented responsiveness to medical needs and allow the industry to provide a more reliable supply of medicines to patients. SVC represents a more flexible, agile and precise manufacturing platform that can operate at conditions that are inaccessible to batch processing which enables safer, more efficient and more environmentally -friendly chemistries. The construction of the SVC facility has enhanced the Lilly SVC platform for the development and launch of new medicines to the market.
The primary goal of Lilly’s small volume continuous (SVC) project was to build a GMP facility that accesses innovative technologies to rapidly deliver new therapies to patients. While some companies are harnessing the benefits of individual continuous processing unit operations in their batch processes, Lilly is the only company with a facility that can manufacture multiple GMP synthetic steps simultaneously through the use of continuous manufacturing technology.
ISPE congratulates the Eli Lilly and Company’s team for their achievements and their FOYA award winning entry for Process Innovation. Learn more about the 2019 FOYA Process Innovation Category winner.
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? ISPE is now accepting entries into the 2020 ISPE Facility of the Year Awards (FOYA) Program, and your facility may be eligible to apply. Learn more about the Facility of the Year Awards submission process and your company could be the next Facility of the Year Awards Category winner.
Facility of the Year Awards Banquet
Join ISPE and prominent industry leaders as we recognize the 2019 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction, and operation, at the FOYA Banquet on the evening of Sunday, 27 October 2019 in Las Vegas, NV during the 2019 ISPE Annual Meeting and Expo.