2024 ISPE FOYA Category Winner for Innovation

Eli Lilly Kinsale Limited

Location: Kinsale, Ireland
Project: IE2b

Eli Lilly recently completed a new synthetic peptide manufacturing platform/facility in its existing Kinsale, Ireland facility. The project was completed safely and resulted in the successful installation of several new process and execution systems, which has earned Eli Lilly Kinsale Limited recognition as the 2024 ISPE Facility of the Year Awards (FOYA) Category Winner for Innovation.

The new IE2b facility uses a hybrid manufacturing platform, liquid phase peptide synthesis/solid phase peptide synthesis (LPPS/SPPS), combining the traditional approaches to synthetic peptide production using SPPS to manufacture high purity pre-assembled peptide fragments combined with coupling the fragments via LPPS using continuous processing technology. This new manufacturing platform enables a significantly increased annual throughput potential and substantially reduces risks during the peptide manufacturing process. IE2b was designed to allow production of synthetic peptides assembled using Eli Lilly’s novel hybrid LPPS/SPPS manufacturing platform. Hybrid LPPS/SPPS combines the traditional approaches to synthetic peptide production using solid phase synthesis of small, high purity peptide fragments with the processing efficiency of liquid phase peptide bond-forming chemistry that leverages continuous processing technology and principles.

An original digital solution for material tracking and generating an accurate genealogy for the continuous process was developed principally for the new hybrid peptide continuous manufacturing platform. The development and implementation of a material tracking model of this scale and complexity for a continuous process represents an industry first and a significant step forward in the use of models to support GMP manufacturing.

The development and integration of innovative continuous flow chemistry and technology, process analytical technology (PAT) control and nanofiltration technology (using ceramic membranes – also a first in the pharmaceutical sector) lends itself to a novel platform for peptide synthesis that can support high-volume throughput of life-saving peptide medicines at a commercial manufacturing scale.

In addition to strong performance in terms of innovation, the Eli Lilly team also ensured a focus on a strong safety culture on this project which was executed during the COVID-19 pandemic. Eli Lilly and its construction partners collaborated very effectively to ensure a “safety first” culture. The project managed over 1.6 million construction hours — ensuring a safe and healthy workplace for everyone working on the project. A primary objective of the project was to ensure a safe workplace for the entire IE2b project workforce for the project's duration (over 600 people at the peak resourcing period). This project was executed in an existing operating campus which added to the level of complexity during implementation.

Internally, this project has been recognized for superior performance with the 2022 Global Lilly IT Award for the project team’s new material tracking system, and the project team was awarded the Lilly Global Safety Award.

Based on these innovative ways of working and implementing this project in a safe and sustainable manner, Eli Lilly Kinsale Limited is recognized as the 2024 ISPE FOYA Category Winner for Innovation, for their IE2b project in Kinsale, Ireland.