Location: Indianapolis, Indiana, USA and Carolina, Puerto Rico
Project: Continuous Direct Compression Manufacturing Kits 2 & 3
When considering an entry worthy of the Facility of the future award, the judges were looking for the application of technology and project delivery to create a step change in our industry’s operating model. Lilly’s process development, production platform commitment and deployment of three replicate operational continuous Oral Solid Dosage production facilities is a worthy winner.
Fundamental to the success of the approach was the development of the progressive mass balance control scheme anchored by advanced automation and PAT technology, key to insuring consistent control, low process variability, and high quality assurance.
The collaboration achieved on these projects between development and multiple manufacturing sites, ensured that the project design was delivered efficiently and effectively. It was made even more impressive considering the level of integration of unit operations and associated reliance on PAT, automation, and controls of the continuous process.
Each of the three OSD installations were built sequentially in existing, operating facilities at three separate geographic sites.
The most significant, lasting benefit of having replicated facilities is reducing technical transfer time for early-phase treatments to commercial manufacturing. Greater speed is possible because process scale, equipment design, and automation is identical from R&D to first Production site and then to multiple site production. Process scale-ups are eliminated, tech transfer times are significantly compressed, and development costs far lower than more traditional operations. This combination of technology and process understanding with identical standardized production platforms is what makes this project the winner of the Facility of the Future Category Award.