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Nearly 20 cranes stretch across the sky at Eli Lilly and Co.’s newest manufacturing site, a sprawling, 600-acre location in Lebanon. The Indianapolis-based drugmaker broke ground on the site last year, and now hundreds of construction workers are busily converting the rugged area from farmland into a massive industrial complex.
Lilly’s investment in the site at the LEAP Research and Innovation District is massive, too: $9 billion, rolled out in three separate announcements. The latest was last week, when the company said it would commit $5.3 billion on top of the $3.7 billion already announced, to triple manufacturing capacity.
The move is intended to help Lilly meet a crush of demand for its diabetes treatment Mounjaro and its weight-loss drug Zepbound, along with drugs in the pipeline for a wide sweep of diseases.
Both Mounjaro and Zepbound, which share the same active pharmaceutical ingredient known as tirzepatide, are on the U.S. Food and Drug Administration’s drug shortages list. Lilly is scrambling to ramp up manufacturing capacity in Indiana and elsewhere.
At the Lebanon site, about a dozen buildings are starting to rise from the ground. In about a year, many will begin to be outfitted with the latest in robotic, digital manufacturing equipment that will do much of the work that a generation ago was done by humans, including analyzing samples and manufacturing drugs and therapies.
Lilly officials declined to say if the Lebanon plant would be the most automated in its manufacturing fleet, other than to say it will use the latest technology with fully automated systems.
“With all our new manufacturing plants, we’re going a step forward with all the technology, all the automation, all the digital systems in these,” said Jennifer Massey, Lilly associate vice president of manufacturing.
Automation covers a sweeping array of functions in manufacturing, including robotics, data analytics, computerized systems and digital processes. It is designed to improve speed and quality and keep the manufacturing process at a high, consistent pace, with minimal human intervention.
Taking samples, for example, involves a lot of steps, such as diluting the samples or adding compounds that cause a reaction. It’s a slow process when done by hand, as some pharmaceutical plants now do. But all the automated equipment in a plant such as this one could handle the job much more quickly, Massey said.
“It will be able to read the sample barcode for traceability, uncap the sample, automatically transfer it to a sample plate, deal with the waste,” she said. “All of that happens through an end-to-end robotic system.”
In recent decades, automation has made huge leaps in pharmaceutical manufacturing and laboratory work. In the mid-20th century already, basic machines like centrifuges marked the first steps toward reducing manual tasks in labs, laying the groundwork for automation, according to Essert Robotics, a German-based maker of scientific machinery.
In the late 1980s, robots entered labs, enabling high-throughput screening and simplifying intricate tasks, the company said. And in the 21st century, advanced software transformed data interpretation, experimental designs and predictive analytics.
According to research from the Association for Packaging and Processing Technologies, 75% of pharma companies said they intend to increase their level of automation in the year ahead.
On one side of the Lebanon construction site, a three-story building is going up that will make active pharmaceutical ingredients (or APIs) for a wide variety of medicines in a dry-powder form that can end up as pills or injectables.
Far across the field, another three-story building is going up that will be used for cell and gene therapies in the form of liquid in vials.
“We’re trying to take a step forward with all these,” Massey said. “Making APIs is quite complex. You’re talking about chemical synthesis processes, and then purification that goes along with them. So just doing that process takes a lot of equipment and infrastructure.”
The drugmaker hasn’t said how this manufacturing site compares to others in size or output—or what the output will be. But it’s clear that the footprint—equivalent in size to more than 400 football fields—will have the capacity to turn out huge volumes of ingredients and therapies.
Lilly hopes to begin producing drug ingredients at the Lebanon site in 2026.
Drug shortages
Much of the glory in drugmaking happens in research and development, where scientists look for new pathways in human biology to treat cancer, Alzheimer’s disease, diabetes and other critical diseases. The research is closely followed around the world and breakthroughs are written up in medical journals.
Manufacturing, on the other hand, can sometimes be seen as tedious or routine. Yet when drugs are in short supply, physicians and pharmacists (not to mention patients) quickly raise a clamor. In the first quarter of 2024, the FDA reported more than 320 drug shortages, the highest in a decade.
Some say new automated plants could hold the key to solving the drug shortage.
“When the manufacturing processes become more efficient in producing medications, hopefully that will lead to consistent volumes of supply and fewer shortages,” said Dawn Moore, chief pharmacy officer at Community Health Network.
A persistent drug shortage crisis in the United States is closely linked to higher mortality rates, medication errors, medication rationing, delays in life-saving cancer treatment and significant financial costs to the health care system, according to a white paper published in March by Duke University’s Margolis Institute for Health Policy.
Advanced manufacturing technologies can reduce per-unit production costs and increase quality consistency, the report said.
They are key to making medicines more available and affordable in the United States, agreed Alina Alexeenko, professor of chemical engineering and associate director of the Institute for Advanced Manufacturing of Pharmaceuticals at Purdue University.
And often that means paying top dollar for equipment and talent, she said. Pharmaceutical companies that invest in U.S. manufacturing are likely to reap big returns, she said.
“Onshoring the supply chain of pharmaceuticals and vaccines is impossible by trying to compete on labor costs,” she said. “We have to win the global competition for speed of innovation and strength of talent.”
Less ‘hands-on’ work
Lilly’s Boone County site will have 900 workers, including engineers, scientists and lab technicians. They will do less “hands-on” manufacturing work and more monitoring and regulating the system.
Those highly skilled workers will replace the machine operators of a generation or two ago, who were heavily involved in many steps of the manufacturing process.
Massey compared the process to cooking. In less-automated drug manufacturing sites, the process is analogous to cooks making candy on the stovetop, she said.
“So you have a temperature probe in your pan on the stove, and you’re stirring, and the temperature goes up a little bit, and so you adjust your burner,” she said. “You have to keep it just right for whatever kind of candy you make.”
But in a highly automated manufacturing center, the workers have more of a hands-off role, she said. Cooking meat on a high-tech grill, for example, allows the machine to do most of the work.
“You put the thermometer in, and it’s connected to your phone, and you can see the temperature anytime, anywhere, and it’s the grill that’s actually doing the adjusting,” she said.
Massey called the advances in manufacturing a “skill change” for the workforce. The workers, instead of doing the step-by-step process, will be focused on monitoring the machinery.
“So it’s just a different type of work,” she said.
The highly automated drug manufacturing line will keep tabs on all the reactions from beginning to end and make adjustments, she said.
“So you have a reactor in the field, the temperature is being monitored by the distributed control system,” she said. “And the system is adjusting the heating and cooling to keep the right temperature range, rather than having an operator out in the field manually doing that. So he’ll be in a control room.”
Out on the construction site, trucks and buggies rumble by as office workers in trailers keep track of the site’s construction. Maps of the site hang on the walls. Workers and visitors suit up in safety gear, including helmets, steel-toed boots, reflective vests, gloves and eye protection.
Massey led an IBJ reporter and photographer around the sites on construction buggies resembling sturdy golf carts. It’s a blur of activity, with workers and technicians crawling over the field in one of the largest capital projects in Indiana history.
The first building to go up was the central utility building, which will monitor heating and cooling in all the buildings. All the automated machinery will use an enormous amount of electricity, part of which will be generated onsite by a small solar farm.
“All these technologies enable us to ensure quality and ensure efficiency for the medicines we’re making,” Massey said. “It’s an investment that will absolutely pay off.”•
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