Lilly's Toolbox For Fast Track Fill Finish Sites
By Katie Anderson, Chief Editor, Pharmaceutical Online
Constructing greenfield fill finish sites is always a complex task, but throw in there the added challenge of delivering the site expediently, and the task becomes increasingly complicated.
That’s what manufactures like Lilly are facing—charged with the responsibility to roll out fully functional and compliant greenfield fill finish sites to meet the needs of the patient and the demands of the industry. Though Lilly utilizes existing tools in their toolbox such as modular construction, stakeholder alignment, effective governance and partner selection, it is the new tools in their toolbox that give them an advantage, according to Massimiliano Ammannito, Senior Director for Facilities, Utilities and Capital Projects at Eli Lilly and Co. At the 2026 ISPE Aseptic Conference, Ammannito detailed the new tools he and his team have utilized to effectively and rapidly construct their new fill finish sites.
Standardized Manufacturing
Elements of the manufacturing platforms can be standardized for quick roll out, according to Ammannito. For example, filling, visual inspection, formulation and material preparation can be standardized.
This allows the company to order the production equipment much earlier, as previously mentioned in a former presentation by Victor Cruz. These standardized manufacturing elements can be replicated between sites, and triggers further replication, according to Ammannito. “When you start to standardize processing equipment, you can start to standardize what is immediately around it,” added Ammannito.
Smart Replication
The next level of standardization and replication goes into what is immediately around the process, such as layout, building, flow, automation and IT infrastructure. In fact, smart replication of facility features like layout, people and material flow allowed Lilly to reduce design of their Concord site by one-third. “All of them came with a significant design element, which we are reducing significantly,” added Ammannito. He added that C&Q can be accelerated and personnel can be trained faster.
Digital Twins
Continuing with replication when it comes to IT infrastructure, Ammannito then went into the benefits of digital twins. In this example, Lilly leverages a digital twin on the first project to streamline IT infrastructure on the next project. “You can do a lot of testing of your automation even offline event before your equipment arrives,” explained Ammannito.
Digital twins are developed for filling lines, formulation, clean utilities, autoclaves and part washers.
Operational Readiness
Lilly focuses on operational readiness early on, according to Ammannito. He explained that this means you must consider this effort not at the end, but as a parallel workstream starting on day one.
“The time you need between when your facility is qualified and the moment when you are really ready to submit your process validation—that gap, if that delay is a delay because operational readiness, is a delay you cannot afford,” emphasized Ammannito.
Start-up Design
The reality of construction is much different than the design, according to Ammannito. Therefore, he recommends building flexibility into the process. “You will be completing a portion of the facility earlier than others and some later than you planned. Design some flexibility so that you don’t jeopardize your early start-up because of availability of some portion of the site,” he explained.
Having a satellite QC lab for the early phases was an example of a temporary workaround recommended by Ammannito to keep the project on track.
Finding Good People, Early
Ammannito highlighted how important the people are to a site. “We can have the most robust strategy for a successful delivery of a project, but if we do not have the right people to support what we are planning to do, this is going to fail,” he explained.
A project plan with a headcount and capability needed in each phase is important. The team must then discuss local workforce, where internal hires are available, where a contractor is needed, where these personnel can be found and how to train these people to be ready when they are needed. But do not take short cuts, according to Ammannito.
“For greenfield sites, the first 10 people you hire will determine the quality of the first 100 people you will have on your site later on,” he explained.
Each Project is Unique
Each project will have its unique challenges, according to Ammannito. Therefore, the project leads must be able to see what tools are in their toolbox to solve their unique challenges and apply them. As Ammannito noted in the beginning of his presentation, the ability to review the tools and select the right one is an art form. That being said, speed should never be considered a hinderance. “Speed is not a threat, but our greatest opportunity. It pushes us to really implement what is out there,” he concluded.