Eli Lilly, Merck, Purdue University team to push innovation in sterile injectables
Sterile injectable drugs account for over 40% of new drug approvals, but their production remains slow, costly, and heavily regulated.
With demand increasing, driven by biologics, biosimilars, and high-potency therapies, the Young Institute Pharmaceutical Manufacturing Consortium, a partnership between Purdue University, Eli Lilly, and Merck, is focused on advancing AI-driven automation, robotics, and novel aseptic processing methods to improve efficiency, quality, and safety in injectable drug manufacturing.
The global sterile injectables market is projected to hit $1.4 trillion by 2030, growing at 9.7% annually. Rising demand for chronic disease treatments is a key driver, with Eli Lilly’s diabetes and obesity injectables, Mounjaro and Zepbound, generating $4.4 billion in Q3 2024 alone. As pharma companies scale up production, the Young Institute is working to address bottlenecks in efficiency, contamination control, and regulatory compliance.
In a conversation with Pharma Manufacturing, Elizabeth Topp, director of the Young Institute, outlined the consortium’s approach to tackling these challenges.
Faster, smarter sterile manufacturing
One of the consortium’s primary focus areas is lyophilization (freeze-drying), a critical but slow step in injectable drug production. The method is widely used for biologics and vaccines but can take days to complete, delaying overall production.
“We’re looking at a range of new unit operations for drug product manufacturing,” Topp said. Young Institute Co-Director Alina Alexeenko is leading research on radiofrequency-assisted lyophilization, a technique designed to significantly reduce drying time while preserving drug stability.
Beyond freeze-drying, the consortium is exploring artificial intelligence-driven process control, robotic automation, and digital twin modeling. AI could monitor and adjust manufacturing conditions in real time, improving efficiency and reducing batch failures.
“Recently, we submitted a proposal to the National Institute of Standards and Technology (NIST) to create a new Manufacturing USA Institute dedicated to applications of AI in pharmaceutical manufacturing,” Topp said.
Robotics could remove human operators from sterile environments, reducing contamination risks and ensuring operator safety. Digital twins, computational models of manufacturing processes, would allow companies to simulate process adjustments without disrupting production, potentially cutting costs and minimizing downtime.
These innovations are particularly relevant as companies like Lilly invest heavily in expanding sterile injectable production, with last month’s announcement of a $27 billion investment in four new U.S. manufacturing facilities.
Bridging research and industry needs
The Young Institute’s research priorities are shaped by the pharmaceutical industry’s most pressing challenges. According to Topp, the consortium does not dictate research topics in isolation, but rather works directly with industry partners to identify bottlenecks.
“Our member companies are interested in better methods for monitoring air purity in sterile manufacturing environments,” she said. “Purdue has one of the best analytical chemistry departments in the world, and I have no doubt that they can come up with effective new monitoring methods.”
Air quality is just one example of the technical gaps the consortium aims to address, ensuring that sterile injectable production meets safety and efficiency standards.
Training the next generation of pharma engineers
As demand for injectable drugs increases, so does the need for skilled professionals in pharmaceutical manufacturing, AI, and automation. Workforce development is a core focus of the Young Institute, which is launching several initiatives to train the next generation of pharmaceutical engineers.
The institute will host a week-long pharmaceutical manufacturing program in summer 2025, supported by the National Institute for Innovation in Biopharmaceutical Manufacturing, aimed at giving students hands-on exposure to industry challenges.
Additionally, the Heartland BioWorks initiative, funded by the U.S. Economic Development Administration, is expanding industry-focused workforce training. Purdue also offers a Certificate in Pharmaceutical Manufacturing and a Professional Master’s Program in Pharmaceutical Engineering, designed to provide specialized expertise in advanced aseptic manufacturing.
AI, digital twins, and smarter manufacturing
AI and automation are playing an increasingly central role in transforming aseptic drug production. The Young Institute is actively involved in AI research, recently submitting a proposal to the National Institute of Standards and Technology to establish a Manufacturing USA Institute focused on AI in pharmaceutical manufacturing.
“AI, robotics, and digital technology have the potential to transform pharmaceutical manufacturing,” Topp said. “Digital twins and other modeling techniques could support adaptable manufacturing processes, and AI and machine learning could enable automated process control to ensure product quality.”
The proposal, led by Alexeenko, has attracted participation from over 100 pharmaceutical and technology companies, demonstrating industry-wide interest in AI-driven manufacturing improvements.
Regulatory barriers to innovation
Despite the promise of automation and AI in sterile injectable manufacturing, regulatory oversight remains a key challenge. The FDA requires that any significant change to a drug’s manufacturing process be reviewed and approved, adding time and cost to new technology adoption.
“Most people know that the quality of pharmaceutical products is monitored by government agencies such as the FDA,” Topp said. “What’s less well-known is that the processes used to make those products are also monitored. Every New Drug Application includes a description of the manufacturing process, and significant changes require additional regulatory review and approval.”
These regulations, while essential for ensuring drug safety, can slow down the adoption of new and improved manufacturing methods. The Young Institute is proactively working with regulators to integrate compliance into the research process, helping accelerate approvals for advanced manufacturing technologies.
Future milestones
To encourage broad industry participation, the consortium offers tiered membership options for pharmaceutical manufacturers, contract development and manufacturing organizations, startups, and equipment providers. Founding members like Lilly and Merck help define strategic research priorities, while smaller members contribute to pre-competitive research and technology development.
“We hope that this structure enables startups, contract manufacturers, and equipment providers to participate in the consortium at a level that suits their needs,” Topp added.
The future of injectable manufacturing
Several key milestones are ahead for the Young Institute. A 10,000-square-foot pilot-scale manufacturing facility is under renovation and expected to reach partial occupancy by late summer 2025. The first collaborative research projects will launch soon, with initial results expected within a year.
As the first research projects launch and manufacturing capacity expands, the consortium is positioning itself to advance the future of sterile injectable manufacturing, making it more efficient, scalable, and resilient.
