TIDMEKF
EKF Diagnostics Holdings PLC
26 October 2023
RNS Reach
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
Julian Baines, Executive Chair Tel: +44 (0)29 2071 0570
Singer Capital Markets (Nominated Adviser & Tel: +44 (0)20 7496 3000
Broker)
Aubrey Powell / Oliver Platts
Walbrook PR Limited Tel: +44 (0)20 7933 8780 or 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 <BETA>-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
)
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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