Opening of new US State-of-the-art Life Science Manufacturing Facility

Opening of new US State-of-the-art Life Science Manufacturing Facility

EKF Diagnostics Holdings plc (AIM: EKF), the AIM-listed global diagnostics business, announces the official opening of its new state-of-the-art Life Sciences manufacturing site in South Bend, Indiana, United States, one of the US’s major Life Sciences and industrial centres/hubs.

EKF Life Sciences is a specialist global manufacturer of high-quality enzymes and custom products for use in diagnostic, pharmaceutical and industrial applications. The Company is at the forefront of supporting life sciences global demand in precision fermentation, enzyme applications and research, providing innovative biotechnology solutions to deliver breakthrough discoveries and advancements in healthcare and medicine.

The Company’s state-of-the-art facilities and leading technical expertise in specialist enzyme production uses precision microbial fermentation and cutting-edge downstream processes, to isolate and deliver the highest quality enzymes and biomolecules that have been specially engineered to customer specifications. 

The new 24,000 square foot state-of-the-art facility addresses a significant gap in the US market for mid-volume manufacturing and will enable EKF to meet the increasing demands of its growing customer base. As part of its investment programme, EKF has installed 10L, 65L, 300L, 1,500L, 3,000L and 14,500L units as well as key upstream and downstream process capabilities at its South Bend plant. The cutting-edge, intelligent design of the Group’s modular platform includes bioreactors ranging from 5L to 14,500L to enable it to deliver an end-to-end service from bench/proof-of-concept through to full scale commercial production. This efficient and scalable platform allows multiple batch cycles to run in parallel, enabling greater process control and precision to deliver effectively the desired yields.

The South Bend site is currently operating with full fermentation capabilities and is also expected to have all downstream processing capabilities fully operational by December 2023.  As previously announced, the Company has already received the first purchase order for precision fermentation services for the new facility and has a strong contract pipeline, with onboarding underway for a number of existing OEM customers and the potential to develop into long-term strategic partnerships. During 2024, the Company expects to see a steady build-up of revenues generated from this new capacity and, as contracts scale-up, EKF Life Sciences is expected to deliver substantial, long-term sustainable growth.  

The South Bend site is located in close proximity to the Company’s existing 20,000 square foot facility in Elkhart. Both sites operate to the highest regulatory standards under cGMP (current Good Manufacturing Principles), ISO 9001 and ISO 13485 Quality Program. 

Julian Baines, Executive Chair, commented: “I’m delighted to announce the opening of our new state-of-the-art manufacturing facility in South Bend. The increased application of specialty enzymes is driving the demand for precision fermentation services and in the US market there is a large gap for specialist mid-volume, scalable manufacturing services. We believe EKF is the only Company in the US with the GMP capabilities and unique technical expertise to provide scalable, mid-volume manufacturing from 5L to 14,500L, so we are well placed to meet the distinctive needs of our growing customer base. This is a very exciting opportunity for EKF and we expect it to deliver significant long-term revenue growth.”