Lateral Flow Development: Efficient Product Design and Development Processes
Read the latest blog from Abingdon Health's Chief Technical Officer, Nina Garrett, who will be speaking at the Merck 2025 Rapid Diagnostic Test Development Conference in Vancouver, Canada, 1 — 2 April 2025.
Introduction
Lateral flow testing has been a cornerstone of point-of-care diagnostics for more than three decades. It offers cost-effective, easy-to-use, and portable solutions across multiple industries, including medical and environmental applications. The COVID-19 pandemic significantly expanded the awareness and adoption of this technology; and has brought innovation to the test format, including the types of biomarkers being detected and the use of new reagents and methods to increase sensitivity.
In this overview, we explore ways for promoting efficient design and development processes for lateral flow tests.
Efficient Design Principles
Efficient lateral flow development means achieving design of a product with minimum wasted effort or expense. This requires, a clear understanding of the product design requirements from the outset of the development program as well as working in a well-organised way managing resources, time, and materials effectively.
Successful lateral flow development begins with clear design inputs, considering multiple factors in a holistic approach.
Consideration of the entire scope of product design and development process and not just technical aspects should be undertaken. Areas such as the intended use of the product, end user needs, market territories and the expected route to market will all need to be factored into the product development plan early on along with other factors such as final kitting and packaging requirements, regulatory requirements and environmental considerations.
Early input into all of these areas ensures that you have a good understanding of your product requirements and are making informed decisions from the start of the development process.
Early Technical Development Phase
Early technical development activities focus on establishing whether the fundamental concept can work. Understanding the target analyte to be detected; establishing that the raw materials are available to develop the lateral flow test; and determining if the performance requirements are feasible are all key activities in this phase. Additionally knowing how the end user will use and interpret the test will direct key selections of test materials and how the protocol to take the test is developed.
Process Scale Up
Scaling up of the test manufacture involves transferring specifications from small scale R&D batch preparations into the manufacturing environment. This is a crucial phase as a successful scale up will ensure the product can be manufactured reproducibly at scale.
The design and development early phases should heavily focus on design for manufacture, as the majority of manufacturing costs derive from early design decisions regarding materials selection and manufacturing process development.
Key Areas to consider are the equipment and compatibility of the production equipment with the process that has been developed. Additionally knowing what scale is required for routine manufacturing long term is important to ensure that the most cost-effective processes are put in place for ongoing batch manufacturing.
Facilities should also be considered e.g. do you have the correct environmental controls and do they align with the necessary manufacturing process.
Training of the manufacturing team is also critical to ensure that the process that was developed by the development team is correctly translated to the manufacturing teams.
Outsourced Manufacturing
Another option is to outsource your manufacturing. Working with an experienced contract development and manufacturing organisation (CDMO) with knowledge and expertise in design, development and transfer of products can be efficient and cost-effective long term for a number of factors including having the experience to manage your product effectively post launch. An experienced manufacturing team will have the capability and resource to troubleshoot any issues seen with the product in manufacture or even design Generation 2 of your test.
The Key Takeaway
Efficient lateral flow development requires:
- Well-defined design inputs and comprehensive product understanding from the outset.
- Overview of the entire product development pathway.
- Well-planned early phase evaluations
Working with developers experienced in all aspects of product design results in efficient, cost-effective product development that moves smoothly from concept to commercial success.
Abingdon Health’s team has over 20 years' experience in the lateral flow market and is a knowledge leader in the development, scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors. If you would like to understand more about the development, technical transfer, manufacturing and regulatory process and discuss any specific requirements don’t hesitate to contact Abingdon Health's highly experienced team.
