Diagnostics CDMO services: development, scale-up and manufacture

Designed for market launch, from the first prototype.

CDMO services

A test that performs well in development can still fail commercially. Materials that cannot be bought at volume, processes that will not transfer and costs that climb at scale are the usual culprits, and each is far cheaper to solve at feasibility than after design freeze.

Our CDMO teams develop, transfer and manufacture lateral flow and other IVD formats under one quality system, so the people who will make your product have a say before its design is fixed. You can engage us for a single phase or for the whole programme.

Abingdon Health team reviewing production

Built for companies that can’t afford delays

We understand the pressure facing diagnostic companies after securing funding or pharma partnerships. Your investor presentations included aggressive timelines. Your board expects execution. Every month of delay erodes competitive advantage and consumes capital without generating revenue.

Our integrated approach directly addresses this challenge. Because lateral flow development, scale-up, manufacturing, and regulatory support operate under one roof, you avoid the coordination delays inherent in managing multiple vendors across different organisations and time zones. Technical questions don’t require scheduling international calls; they get resolved by teams working in adjacent buildings.

This integrated approach compresses concept-to-commercial timelines compared to fragmented CDMO relationships. In markets where category leadership often goes to the first company with a validated product, this advantage can be decisive for long-term success.

Assay development

Lateral flow test development

Our immunoassay development processes are designed with scale-up and manufacturing being a major consideration from the outset of any project. A multi-disciplinary team and a partnership-led approach alongside a focus on operational excellence, produces reliable rapid tests irrespective of their complexity.

Helping rapid test concepts become a reality

Our diagnostics CRO research & development team is proud of their many years’ experience working with a global, multi-industry client base. By combining experience and passion we work closely with clients to produce tests that make a difference: this is what drives us.

Our key focus from day one is “design for the user” and “design for manufacture”. This ensures we focus on cost-effectiveness, scalability, and usability, as well as technical performance. Our experienced CRO team have a long-established track record of high quality, effective lateral flow rapid tests across, inter alia, the clinical, animal health, food, plant pathogen and environmental testing markets.

Our process

Whether a project starts during concept and planning or optimisation, our established methods produce robust assay specifications suitable for routine LFT manufacture.

  1. Step 1 of 3: Concept and planning phase

    • Define market, product, supply and regulatory requirements
    • Production of a phase-by-phase project plan. A parallel desktop or Smartphone reader customisation plan will be drawn up if applicable.
  2. Step 2 of 3: Assay feasibility and optimisation

    • Evaluation of specifications and materials
    • Pilot batch
    • Assessment of prototypes
    • Optimisation of formulations, reagents and materials
    • Design freeze
  3. Step 3 of 3: Scale-up and transfer to manufacture

    • Validation batches at small, medium and delivery batch scale
    • Manufacturing schedules and processes for transfer to manufacture

Tailored diagnostic assay development

Whether looking to develop new tests, or transfer existing ones for use in the field, Abingdon Health helps its customers:

Develop rapid test solutions for both single and multiple analytes

Convert lab-based assays (e.g. ELISA) to lateral flow for use at the Point of Care (POC)

Design semi-quantitative or quantitative lateral flow testing solutions

Navigate complex regulatory, legal, and commercial barriers to launching products to market

From development to manufacture

Focus in the following areas allows us to transfer tests from development into routine lateral flow manufacturing:

Defining optimum user protocols and sample preparation for different sample matrices (blood, serum, urine, milk, food, plant material, plus more)

The use of optimum conjugation techniques and immunoassay formats depending on the target

Choosing the right quality raw materials: antibodies, reagents, nitrocellulose membranes and labels (colloidal gold, carbon, latex, plus others).

Securing a sustainable supply of materials via our established supply chain

Optimum configuration with applicable desktop or Smartphone readers

Offering stable costs from development through to market entry

Scale-up and technical transfer

A design-for-manufacture approach to diagnostics

Our Scale-up and Technical Transfer team are dedicated to bringing lateral flow and other diagnostic products from development through to manufacturing. Our expertise lies in ensuring your product can be transferred under our quality management system into manufacturing at scale in a repeatable, cost-effective and robust manner.

We bring in development projects from customers at this stage or we seamlessly work with our in-house CRO team to transfer products that have undertaken proof of concept and optimisation at Abingdon Health. Importantly our CRO & CDMO teams are all focused from day one on “design for manufacture”, to ensure cost-effectiveness, scalability, and usability, as well as technical performance.

Our Technical Transfer team have a long-established track record of scaling up and transferring into manufacture high quality, robust lateral flow rapid tests across the clinical, animal health, biosecurity, food, plant pathogen and environmental testing markets, amongst others.

Key aspects of scale-up and technical transfer include ensuring that the supply chain is scalable and that all components and reagents can be procured at volume, cost-effectively. In addition, the team focus on transferring lateral flow products onto our high-throughput instrumentation, building Standard Operating Procedures (SOPs), Bills of Materials (BOMs) and controls, so that once transferred to manufacturing, batch production is robust and repeatable.

Our process

Whether or not our CRO team has completed the R&D proof of concept and optimisation phase work, our Technical Transfer experts help our customers:

  1. Transfer processes from bench to routine manufacture after Design Freeze

  2. Implement formal QC methodologies for each project

  3. Identify, tailor and implement a strong supply chain

  4. Manufacture the pilot batch

  5. Deliver 3x Technical Transfer validation batches of each product, from minimum quantity to routine manufacture batch size

  6. Develop formal SOPs and BOMs

  7. Complete final output review(s)

Manufacturing and packaging

Lateral flow test manufacturing

Abingdon Health’s state of the art rapid test manufacturing service is available to our internal assay development customers or clients looking to transfer their lateral flow test from third-party developers or manufacturers. Established supply chains and advanced high-volume flexible manufacturing processes are tailored to assay specifications and market demand of all sizes.

Our experienced CDMO team provide manual and automated test strip, housed device and fully packaged kit manufacture.

Reliability and the consistent delivery of quality lateral flow tests

By working with established material suppliers and combining experience with the latest lateral flow manufacturing automation, Abingdon Health assures the security of supply for all tests and markets, no matter how complex.

With a capacity to produce millions of rapid tests across multiple manufacturing sites, we offer flexible solutions for card and test strip manufacture through to producing assembled devices and kits.

Production runs in York, UK and at our new manufacturing hub in Madison, Wisconsin, so supply can sit close to the markets you serve.

Abingdon Health’s in-house packaging experts work with customers to design packaging, to test packaging through to putting in place the supply chain and managing ongoing requirements such as labelling. We also offer a packaging service to put together all the constituent parts of your lateral flow test in an efficient and controlled manner.

Whether you’re looking to expand into new territories with a new or second manufacturer or have outgrown your current LFT manufacturing solution, we offer flexible solutions to meet your needs.

Flexible and adaptable manufacturing solutions

Whether working with newly developed lateral flow assays or tests already on the market, Abingdon Health helps its customers:

Part or full manufacturing solutions

Transfer new and existing manufacturing Standard Operating Procedures into routine manufacture

Troubleshoot test performance and optimise test recipes and specifications

Conduct scale up from bench to automated manufacture

Navigate complex regulatory, legal, and commercial barriers to launching products to market

Long-term support

Lateral flow test cassettes

Card and test strip manufacture through to assembled devices and kitting

Low, medium and high-volume automated manufacture across multiple sites

Scalable solutions in line with growth plans

Adaptability in response to spikes in demand

Stable pricing for budget planning

International shipping and supply chain management

In-house regulatory and commercialisation support

Abingdon Health leadership team

An extension of your team

Abingdon Health is proud of being approachable and values its long-term customer-partnerships.

Our team of lateral flow specialists are honoured to share their experience and expertise in pursuit of achieving the best for our customers’ product portfolios.

We also advise on next generation developments, continuous improvement plans and go-to market strategies and offer commercial and regulatory support.

Agility Flexible and scalable solutions to meet growth forecasts while offering contingencies to cope with spikes in demand.
Fulfilment Batches produced on-time and in-full via established procurement, project management and manufacturing processes.
Reach Regulatory, commercial and logistics solutions to reach your key markets wherever they are in the world.

Case study

MiraVista Diagnostics Assay Development for Systemic Mycoses

Discover how Abingdon Health partnered with MiraVista Diagnostics on lateral flow assay development, manufacturing and CDMO services.

Discuss your diagnostic programme

Contact our team to see how we can take your diagnostic from idea to commercial success.