RCS - EKF Diagnostics Hldg - Opening of new US LS Manufacturing Facility

EKF Diagnostics HoldingsAnnouncement

26/10/2023 07:00

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RNS Number : 3135R  EKF Diagnostics Holdings PLC  26 October 2023

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EKF Diagnostics Holdings plc

("EKF", the "Company" or the "Group")

 

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

Unique GMP capabilities, addresses a significant gap in the US market for
scalable mid-volume manufacturing

 

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 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."

 

 EKF Diagnostics Holdings plc         www.ekfdiagnostics.com (http://www.ekfdiagnostics.com)
 Julian Baines, Executive Chair        Tel: +44 (0)29 2071 0570

 Singer Capital Markets (Nominated Adviser & Broker)                           Tel: +44 (0)20 7496 3000
 Aubrey Powell / Oliver Platts

 Walbrook PR Limited                  Tel: +44 (0)20 7933 8780 or ekf@walbrookpr.com (mailto:ekf@walbrookpr.com)
 Stephanie Cuthbert/ Kiki Zaccagnini  Mobile: +44 (0)7796 794 663

 

About EKF Life Sciences

 

EKF Life Sciences is a specialist global manufacturer of high-quality enzymes
and custom products for use in diagnostic, pharmaceutical, and industrial
applications.

 

EKF Life Sciences is at the forefront of supporting global demand in precision
fermentation, enzyme applications and research, providing innovative
biotechnology solutions to deliver advancements in healthcare and medicine.

 

Utilising its unique technical expertise, the EKF Life Sciences uses precision
microbial fermentation and advanced downstream processes to isolate and
deliver the highest quality enzymes and biomolecules that have been specially
engineered to customer specifications.

 

EKF Life Sciences has two state-of-the-art GMP manufacturing facilities,
located within close proximity, in Elkhart and South Bend Indiana, one the
US's major life sciences and industrial hotspots. It operates to the highest
regulatory standards under cGMP principles, FDA certification and ISO 13485
Quality Program. The facilities include bioreactors ranging from 5L to
14,500L, enabling it to offer an end-to-end service from
bench/proof-of-concept through to full scale commercial production, providing
its customers with desired yields, precision at scale and cost-efficiency.

 

EKF Lifesciences is also one of the market leaders for the supply of β-HB, a
reagent used to detect ketones for patients suffering from diabetic
ketoacidosis, as well as many other clinical applications.

 

About EKF Diagnostics Holdings plc (www.ekfdiagnostics.com
(http://www.ekfdiagnostics.com) )

 

EKF is an AIM-listed global diagnostics business focussed on:

 

·    Point-of-Care analysers in the key areas of Hematology and Diabetes,
as well as Central Laboratory products including clinical chemistry reagents,
analysers and centrifuges.

 

·      Life Sciences services provide specialist manufacture of enzymes
and custom products for use in diagnostic, food and industrial applications,
as well as other higher value Contract Manufacturing services.

EKF has headquarters in Penarth (near Cardiff) and operates five manufacturing
sites across the US and Germany, selling into over 120 countries world-wide.

 

 

 

 

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