Located on the Eli Lilly and Company manufacturing campus in Kinsale, Ireland, the IE2b Peptide Manufacturing Facility is a state-of-the-art complex that represents years of innovation, teamwork, and attention to detail. The facility manufactures crude drug substance synthetic peptides that can be shipped to other sites for final product purification, isolation, and packaging.
In designing the facility, the Eli Lilly team took a step back from the traditional synthetic peptide manufacturing process to evaluate best practices from the world of peptides and beyond. The resulting vision was a first-of-its-kind hybrid active pharmaceutical ingredient (API) synthetic peptide manufacturing platform that could support high-volume production of life-saving peptide medicines at a commercial scale.
“There were more barriers to doing this than anyone could imagine, but we put a group of people together who were thinking big with a bold, can-do attitude. It’s amazing to see what can be achieved and has been achieved here,” said Darragh McDonagh, Senior Director of Engineering at Eli Lilly Kinsale Limited.
The now active IE2b facility uses a combination of innovative technologies, including a novel hybrid manufacturing platform that significantly increases annual throughput and reduces risks during the peptide manufacturing process. Continuous flow processing and a first-of-its-kind nanofiltration system remove the need for downtime between steps while ensuring more precise control of reagents and materials. Meanwhile, process analytical technology (PAT) lends visibility and control, allowing the team to seamlessly manage stoichiometry to ensure high-efficiency reaction step conversions and yields.
Equally integral to the new manufacturing platform and facility is its digital mandate and material tracking model that marries the flow process with digitization. With this model, facility personnel can determine what raw material inputs are in any process step or item of equipment at any point in time. Together, these features enable a robust, data-rich process control strategy and significantly reduce the traditional time-consuming workload, complexity, and risk of completing these calculations manually.
The emphasis on cross-functional collaboration and risk mitigation, including investing in proven technology and consulting with regulators along the way, paid off for the team behind the project. The facility was finished on schedule, achieved a right-first-time startup, and experienced no significant safety disruptions after over 1.6 million construction hours. A year of operation has revealed the value of high-frequency monitoring, high-quality data, and the ability to control and release batches at an unprecedented rate.
To date, the team estimates IE2b has an annual throughput multiple times higher than traditional peptide production processes. The innovative hybrid manufacturing approach can yield more products with higher quality and less waste. This ultimately brings a more reliable supply of medicines to patients.
About ISPE’s FOYA
Since 2005, ISPE’s FOYA has recognized state-of-the-art projects using new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
Each year, submissions are accepted from projects worldwide, representing breakthroughs in various disciplines, from automation and integration to the development of medicines for underserved populations. Ultimately, a panel of industry leaders chooses the projects that set the standard to receive a FOYA in the following categories:
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