In this article we explore the concept of integration within lateral flow product development, and what considerations are needed when planning your lateral flow project.
Within lateral flow diagnostics the need to integrate development steps, ongoing processes, software systems, and supply chains are key requirements of an effective project plan and should be a major consideration at the outset of any lateral flow project. Four examples below highlight the challenges:
Assay Development & Manufacturing
Lateral flow assay development and lateral flow manufacturing go hand-in-hand, after all the end goal of an assay development project is to produce a finished product in routine manufacture. The decisions made during the feasibility and optimisation phases of the development process can have a significant bearing on the ability to manufacture the product in a cost-effective and efficient manner. Examples for consideration include:
- Is your lateral flow product development process fully traceable, taking into account the key requirements for applicable regulatory filings?
- Are the materials being used appropriate and available in sufficient quantities for manufacturing at scale?
- Is the technical file you are preparing through the development project suitable for technical transfer to your preferred manufacturing partner?
Assay & Reader Development
Quantitative lateral flow assays are becoming an increasingly important part of the $5bn lateral flow market. This demand is also driving the growth in reader revenues. According to MarketsandMarkets, the lateral flow reader market is forecast to grow at 8.9% per annum to reach $1.3bn by 2022. (Note: Following the COVID-19 pandemic the lateral flow market is expected to be valued at $10.2bn by 2025)
A quantitative lateral flow test development programme should consider reader options at an early-stage ideally with both projects operating in parallel. Prototype field-testing is much more valuable if it evaluates both the reader and the assay at the same time, so that product performance is measured and tested as a complete solution.
Reader System Integration
End-user requirements, user interface and testing workflow, should be a key part of your reader development plans. Who will be using your reader and what are their requirements? Is the reader straightforward to use in the required environment? Will your reader operate on a stand-alone basis, or does your reader system need integration into middleware software to enable electronic transfer of results? What other forms of connectivity are required such as Bluetooth or Wi-Fi? These elements need to be considered at an early stage when evaluating the choice of available readers to ensure that the preferred reader has sufficient flexibility and capability.
Ensuring your supply chain is integrated into your processes should be a key area of consideration from the start of your assay development project. Supply chain management integrates key business processes from end user through suppliers, contract manufacturers and third-party logistics partners leading to better collaboration, better planning, and more efficient scheduling. Abingdon develops and manufactures its own lateral flow products and so has significant hands-on experience in ensuring the supply chain is fully integrated into the overall value chain. This integration also ensures that when changes happen, for example to the product specification or the regulatory framework, these can be dealt with in an efficient and timely manner.
In our increasingly complex world, a critical success factor is the ability to effectively integrate all aspects of your proposed solution. It is never too early to consider integration and this should be a core element of your project plan.
How Abingdon Health can help
Abingdon is a fully integrated assay and reader development and manufacturing business working via an accredited ISO13485:2015 quality management system with manufacturing facilities operating to GMP and registered with the FDA.
We can offer a seamless service to minimise integration risk and ensure a smooth and efficient development and manufacturing process. Here are some examples:
- Our technical transfer team ensure full alignment between our assay development and assay manufacturing teams to ensure a smooth transition to scale-up.
- Our assay and reader teams work hand-in-hand on projects to ensure that we take a solution-based approach to your needs.
- We have long experience of lateral flow reagent and material supply and we can support setting up your supply chain to ensure you have the surety of supply as your product is launched and sales grow.
- We have direct experience of integrating lateral flow readers. Our experienced systems integration team can work closely with you to ensure your quantitative assay solution meets your requirements and those of your customers.
To speak with Abingdon Health about our reader and lateral flow product development and manufacturing services please contact us.