Why choose EKF Diagnostics as your contract manufacturing partner?

EKF Diagnostics services are built on the core values of flexibility, understanding, and expertise. Because no two jobs are ever the same we offer a tailored approach to every customer, whether you need an end-to-end solution or just require a knowledgeable partner to provide a partial service, we can support your business.


EKF has contract manufacturing sites in Germany and the USA. Across these locations we can provide scalable solutions to support all business types, from start-ups to industry leaders. The solutions include assistance with configuring your product, sourcing materials, providing state-of-the-art formulation and dispensing facilities all the way through to services such as kitting, labelling and packaging.


We understand the importance of quality, we work with our partners to ensure all product and manufacturing requirements are defined and documented to ensure we produce your product to specification whilst maintaining the highest quality standards.


When you partner with EKF you partner with a global diagnostics company that has a proven track record of developing and manufacturing reliable and quality products for a range of markets and industries.



EKF Diagnostics has over 12 years’ experience in contract manufacturing and is committed to maintaining unparalleled service


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Our Global facilities

Our Global Manufacturing sites have a range of facilities from controlled Laboratories and White Rooms to ISO Class 7 Clean rooms. EKF will ensure your product requirements are understood allowing the appropriate manufacturing environment to be identified.

Pilot production labs

Assess product feasibility and produce small scale production batches in EKF’s Pilot Production Lab. Whether you want to formulate a new reagent or pack a new kit, our skilled scientists and operatives will work with you to develop fit for purpose production and test protocols to take your concept to the next stage.

Contract formulation

EKF Diagnostics can offer scalable contract formulation. All of our sites have the capability to formulate from 20 to 800 Litre mixes with experience in formulation of many reagent types from Phosphate Buffered Saline to complex reagents for molecular kits.

Contract dispensing suites

Our verified dispensing lines are controlled by in-process checks to ensure accurate filling. Our semi-automated pumps allow a variety of volumes of reagents to be dispensed into a range of vessels. With options for manual dispensing lines for process flexibility or automated filling for speed, EKF will have the dispensing solution that best suits your project. 

Kitting suites

Our adaptable white room suites can be used for manual or automated packing to maintain a fast and flexible workflow. 

ISO Class 7 clean rooms

If your product is required to be manufactured within a clean room environment our sites offer ISO Class 7 controlled clean rooms as well as a fully trained team of operatives.





Llandough contract dispensing suite

Contract dispensing suites


Llandough Clean room

ISO Class 7 clean room

EKF, Your outsourced Manufacturing Team

Understanding specifications to deliver your solution.

Steps to outsourcing your manufacturing:


  1. Understanding your Requirements -  We will work with your team to understand your product build requirements, this will enable us to construct a Product Specification that will outline the product configuration, intended use, components required and any technical specifications you may have.

    EKF will become a key part of your team, we aim to understand the intricacies of your product enabling us to determine the best build solutions for your business. 


    We understand that your product is continuously developing and improving, our product specification is a live document that we use to ensure your ideas are captured and controlled throughout this process whilst guaranteeing clear communication between our team and yours.

  2. Developing the Process - Once we have your product requirements defined, our Technical team will begin to develop the build process, this will include designing a project plan that will identify what product set up work is required, what facilities will be utilised and  how this technology will be transferred into scalable production.
  3. Process Validation -  Once the production process has been defined, EKF will design production documentation aligned with ISO 13485 that ensures excellent batch to batch control and full traceability.

    On completion of step 2, we will have a clear idea on the necessary In-process and Final checks to ensure high quality product is consistently produced. 

    EKF encourage the production of 3 validation batches to assess the production process, this enables us to demonstrate that our production process produces product aligned with your requirements. 

  4. Component Sourcing and Management - Working with our team can take the hassle away from component sourcing, during step 1 we will establish what components are required and what the technical specifications are. Once we have this information our procurement team and warehouse management team will take control, all suppliers will be assessed and approved via our approved suppliers list and all stock will be managed into our warehouse utilising our electronic management system. By giving EKF control over your component sourcing we can ensure stock levels are maintained and materials are correctly managed.
  5. Standard Production - Once your product has been fully implemented into our production facility you can benefit from our easy ordering process and quick production turn around.

    Simply send us a Purchase order stating the product code and required quantity and we will manage the rest. 

    Our manufacturing facilities are fully equipped for production and have skilled operators trained in Lean Manufacture techniques. 

    Be kept up to date on your order status with our transparent and responsive Customer Service Team.


  6. Quality Assurance - All products produced in our production facilities undergo a Quality Assurance Review and Release process, this ensures that all products have been manufactured aligned with the approved production processes and have passed the required in-process and final quality control tests.

EKF Life Sciences manufactures enzymes and related biomolecules from bacterial fermentation since 1983


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contract manufacturing journey

Supporting your product development and build

Supply chain

EKF’s global reach and industry presence provides access to a network of suppliers to source high quality raw materials at the best prices.

Label design and control

EKF can design and develop custom label solutions for your product and control and maintain label databases during product manufacture.

Regulatory consultants

Utilise our experienced Quality and Regulatory teams to understand the regulatory pathway for your product.

Product Managers

Work alongside our experienced Product Managers to develop your idea and understand the market and commercialisation requirements.


Design Studio

Our in-house graphic design team can bring your product to life with packaging design based around your brand identity. We can also help with the more mundane tasks like designing IFUs and other documentation.


We have a global network of specialist IVD distributors who can be accessed to support the commercialisation of your product around the world, subject to product registration. 

Our commitment to you

  • Transparent customer service that ensures our customers are kept up to date with the manufacture or development of their product at all stages.
  • Scalable manufacture of products with a high level of batch control.
  • Manufacture of high quality product regardless of the order size.
  • End to end support of the development and manufacture of your product.
  • Fully equipped ISO 13485 certified sites.
  • Skilled and experienced operators trained in LEAN manufacture and GMP (Good Manufacturing Practice).
  • On hand expert technical and regulatory support throughout the process.
  • Access to global supply chain networks to ensure the best raw materials are sourced for your product.






contract manufacturing kitting

Hear from our customers



"EKF Diagnostics have been instrumental in our development as a company. They worked above and beyond their remit to ensure the successful completion of our pivotal milestones. They worked closely with our team to provide solutions and guidance navigating the tricky start-up landscape, whilst providing top-tier products.

In the recent months, they have helped us produce an RUO product for our first client, working to very time-sensitive deadlines on short notice to ensure we made it to the finish line. Furthermore, they have been extremely receptive and adaptive to our evolving product, helping us every step of the way. This continual support is going to be extremely useful in achieving CE validation in the coming month, and we have no doubt that EKF are going prove to be influential in us achieving this."

Elliot Quigley, Project Manager,
Proton Dx

contract manufacturing kitting PrimeStore


"EKF Diagnostics’ contract manufacturing has been a key part of the exponential growth of Longhorn's core product, PrimeStore MTM, since the start of the SARS-CoV-2 pandemic.  Their knowledgeable team of chemists rapidly scaled manufacturing lot sizes from 200 to 1600 liters. Their executive team devoted significant resources to further expand capacity and add additional manufacturing sites to support our growth.  As volumes subsequently ebbed and flowed, EKF was supportive of our needs and production scheduling.  Sourcing from and working with EKF allowed us to devote our capital to other parts of the business while ensuring that we never ran short of product for our global customers."

Jeff Fisher, President
Longhorn Vaccines and Diagnostics LLC