Innovative Manufacturing Platform: The new IE2b facility is designed to accommodate synthetic peptides using Eli Lilly's pioneering hybrid LPPS/SPPS manufacturing platform. The innovative platform combines liquid phase peptide synthesis (LPPS) with solid phase peptide synthesis (SPPS). Traditional SPPS methods for producing high-purity pre-assembled peptide fragments are merged with continuous processing technology, facilitating fragment coupling through LPPS. Peptide drugs have a wide range of medicinal uses including as epitopes to vaccines and their uses in oral solid dosage forms for a variety of indications.
This innovative hybrid manufacturing approach seamlessly integrates the precision of solid phase synthesis for generating small, pure peptide fragments with the efficiency of liquid phase chemistry, leveraging continuous processing technology and principles. As a result, this advanced hybrid manufacturing platform can significantly increase annual throughput potential while reducing risks in the peptide manufacturing process.
Digital Solutions and Advanced Technology: A standout feature of the IE2b project’s new hybrid peptide continuous manufacturing platform is the development of an original digital solution for material tracking and generation of accurate genealogy for continuous processing. This innovation represents a significant advancement in the use of models to support good manufacturing practices (GMP) and marks a milestone as an industry first in the pharmaceutical industry.
Additionally, the development and integration of continuous flow chemistry, process analytical technology (PAT) control, and nanofiltration technology have further enhanced the platform's capabilities. (Nanofiltration technology uses ceramic members, which is also a first in the pharmaceutical industry.) The use of these innovative solutions and technologies pave the way for high-volume production of life-saving peptide medicines at a commercial manufacturing scale.
Safety and Collaboration: This project was executed during the COVID-19 pandemic. Eli Lilly prioritized safety and collaboration throughout the project, amidst the challenges posed during this time. With over 1.6 million construction hours managed, the project maintained a "safety first" culture, ensuring a safe workplace for the entire workforce (amounting to over 600 people at the peak resourcing period). Collaboration between Eli Lilly and its construction partners was instrumental in navigating the complexities of implementing the project within an existing operating campus.
Recognition and Awards: Internally, the project has received acclaim for its superior performance, earning the 2022 Global Lilly IT Award for the new material tracking system and the Lilly Global Safety Award for the project team. These accolades underscore Eli Lilly's commitment to excellence and innovation in every aspect of its operations.
Eli Lilly's IE2b project stands as a testament to the power of innovation, collaboration, and safety in driving transformative change. By pushing the boundaries of traditional manufacturing processes and embracing advanced technology, Eli Lilly continues to lead the way in the pharmaceutical industry. As the recipient of the 2024 ISPE FOYA Category Winner for Innovation, Eli Lilly sets a standard for excellence that inspires organizations to reach new heights in innovative facility design.
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The recipients of the 2024 FOYA category awards will receive formal recognition during the 2024 FOYA Banquet and Awards Celebration in Orlando, Florida, USA, scheduled for Sunday, October 13, 2024. This banquet, held as part of the 2024 ISPE Annual Meeting & Expo, will include acceptance speeches by the awardees, keynote sessions led by prominent industry figures, and ample networking opportunities with pharmaceutical manufacturing and engineering professionals.
Register for the 2024 ISPE Annual Meeting & Expo and FOYA Banquet and Awards Celebration
About the ISPE FOYA Program
Established in 2005, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.
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