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Scale-up for medical device contract manufacturing in Cardiff
Following the unprecedented success of its medical device contract manufacturing business, EKF Diagnostics has expanded its Cardiffbased facilities twice within six months.
In early 2021, EKF opened new, larger manufacturing facilities at Llandough Trading Estate to increase production of PrimeStore® MTM viral transport media, a key component for the COVID-19 testing regime. Just six months on from this opening, EKF has further developed its production area, warehousing and work force with the opening of two more adjacent units.
The additional units, which include cleanroom facilities, triple EKF’s existing manufacturing area at Llandough to nearly 2000m2. This latest manufacturing area expansion, which can accommodate a further 100% increase in workforce, will now enable EKF to fill up to 100,000 PrimesStore MTM tubes daily. This will ensure they can meet the ever-increasing UK and EU demand for this novel, patented sample collection device successfully evaluated for effective SARS-CoV-2 inactivation by Public Health England.
An established device for safe and easy transportation of pathogenic samples, millions of PrimeStore MTM tubes have now been sold globally during the SARSCoV-2 pandemic, and EKF has continued to receive escalating numbers of orders from healthcare, education and industry for
COVID-19 testing programmes. As well as the additional manufacturing capacity in Wales, EKF has also increased production at its facilities in Barleben, Germany, and the USA in Boerne, Texas, and South Bend, Indiana.
In addition to the increased floor space, EKF has quadrupled its Cardiff-based workforce at a time when many companies have been forced to make redundancies. The new facilities, fitted out using only local contractors, can now accommodate up to 80 staff operating six tube filling pump lines and eight production lines for sample kit assembly. Since September 2020, EKF has already created 54 new jobs, including production line operatives, and in quality assurance, customer services, purchasing, operations and logistics to meet the demand for PrimeStore MTM. EKF expects to employ even more staff as it expands into the new facilities.
The success of PrimeStore which has necessitated the increased production capacity is due to high-volume customers, such as PHE and the NHS, as well as MyHealthChecked plc, the supplier of Boots’ COVD-19 home testing kits. Orders from other customers, including global industry partners, have also escalated as they realise PrimeStore is helping them to significantly streamline their sample collection and testing processes.
Leicester University has established an asymptomatic SARS-CoV-2 screening programme to support and reassure staff and students on campus, and to reduce viral transmission. “By choosing PrimeStore MTM with its viral inactivation properties, we are ensuring the safe transportation and processing of participants’ samples and ensuring protection for our staff,” said Dr Rebecca Allsopp, Research Associate at Leicester Cancer Research Centre, University of Leicester. “We have the reassurance of RNA stabilisation, protecting sample integrity at room temperature without the need for additional storage requirements. EKF has also provided excellent customer service.”
With the continued and significant growth in its manufacturing capabilities, including the addition of two cleanroom facilities and extra warehousing, EKF can also now offer a range of contract production services to other medical device companies.
“We are proud to be bucking the current employment trend in Wales by taking this strategic decision to further increase the size of our manufacturing facilities in Cardiff. Our new facilities provide EKF with a unique positioning for companies looking for contract manufacturing facilities and allow us to ensure our increasing staff numbers can operate in a safe and secure environment.”
Julian Baines EKF’s CEO
These include full capability for labelling, commercialisation, regulatory support, GTIN barcode encoding and usability testing, amongst other services.
The new Cardiff facility has also become a distribution hub for EKF’s latest portfolio addition related to the COVID pandemic, the Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit. It is one of first tests in the world to detect both the presence and precise levels of COVID-19 neutralising antibodies.
