Outsourcing Lateral Flow Test Manufacture: An increasingly layered solution to meet a global demand

Lateral Flow Test manufacturing has become more sophisticated in recent years. Our latest article explores how opening the mind to outsourcing production enables test owners to consider a flexible approach that may prove to be more attractive from a geographic or cost perspective.

The increasing sophistication of outsourced solutions

Outsourced lateral flow manufacturing solutions used to be predominantly a binary proposition – A partner would be chosen; transfer or development of manufacturing processes would take place, and then the partner would produce the tests to the customer’s requirements.

However, recent years have led to an increasing sophistication in outsourced solutions.

Evolving Landscape

The Covid-19 pandemic saw political administrations in many territories attempt to build end-to-end manufacturing capacity for fear of supply chain pressures. This however was, and still is equated to building a house on sand. There are many who work in the diagnostic space who will attest that there is very rarely a diagnostic device that does not rely on an international supply chain for components or biologicals to successfully deliver finished tests to the end customer.

What does Manufacturing Capacity mean?

Unfortunately, not one size fits all. This statement is very true when looking at the manufacturing sequencing for lateral flow tests. Primary production capacity (the production of strips and cards) builds at a different rate than secondary production (assembly and kitting) capacity. Without clever planning this imbalance leads to over-capacity in one and under-utilisation in the other when attempting to balance your manufacturing solution. This can be difficult to balance, especially where there is an insistence on building an in-house ‘end-to-end’ capability.

Grasping opportunities with a flexible approach

Organisations looking to solely manufacture lateral flow tests in-house will be forced down a route of playing ‘the long game’ when it comes to seeing return-on-investment and optimal utilisation. However, by adopting a more hybrid approach and opening the mind to outsourcing production wholly or partly to third party contract manufacturers, organisations can avoid the cost trap of building an ‘end to end’ in-house solution.

As mentioned, many critical reagents and components are sourced elsewhere through necessity, therefore the outsourcing process is not novel. A simple shift of the boundary of thinking to what could be outsourced unlocks a significant opportunity for both new and old lateral flow test businesses.

It is for this reason why open-minded companies are reaching out to contract manufacturers to outsource part of their lateral flow manufacturing sequence, resulting in a hybrid solution.

Depending on the focus and ambition of a lateral flow test company, organisations are increasingly investigating a layered solution. The permutations are many and include:

• Outsource membrane treatments and Primary production card spraying and manufacture only
• Supplying a contract manufacturer with cards to complete secondary device and kit assembly
• Outsource the complete Lateral Flow Test manufacture completely

Outsource membrane treatments and primary production card spraying

There are many reasons why outsourcing primary production only is an attractive option. It allows a Lateral Flow business to use the experience of an established contract manufacturing partner to produce the more technical aspect of the lateral flow manufacturing sequence. Reagent handling, manufacturing within tight tolerances and producing in bulk are just a few of the advantages.

Cards can be transported safely with the correct storage and shipping conditions, and they can be manufactured and dispatched in bulk for the secondary process to be undertaken locally.

In such a scenario working with a recognised ISO13485 manufacturer who has already invested and has all the necessary equipment and capabilities in place is critical for the assurance of consistency and quality of the cards. With the ‘technical’ production steps in a safe pair of hands, a lateral flow business can then, if they so choose to, complete the ‘manufacturing’ domestically while also avoiding additional shipping costs from shipping bulky ‘plastic’ devices or complete kits.

Supplying a contract manufacturer with cards to complete secondary device and kit assembly

There may be a case where cards are outsourced as above, however the lateral flow business does not have the capability for automated assembly. Investment in assembly equipment and manual assembly solutions may be prohibitive. In that scenario the recruitment of a contract manufacturer to complete secondary assembly makes perfect sense.

By partnering with a contract manufacturer for secondary production sequences, a company can take advantage of a market with cards produced either from in-house or third-party sources and avoid the cost and utilisation headache of implementing their own assembly. The secondary production contract manufacturer takes on the responsibility of incoming QC of cards and materials delivering final product and kits to the customer and their distribution points.

In summary

Lateral Flow Test manufacturing has become progressively more sophisticated – In many cases a robust hybrid, part manufacturing solution may be a requirement or prove to be more attractive from a geographic or cost perspective.

With the wide understanding that critical biologicals and components are sourced from international third parties, it is only a small step to manufactured sequences also being sourced from third parties.

Cost and utilisation are pitfalls that are difficult to avoid when setting up ‘end-to-end’ in-house manufacturing capability. These include increased overheads, machinery costs, offsetting quality cost – all are avoidable through the implementation of a third-party contract manufacturing solution, either in part or complete.

Taking advantage of contract manufacturing solutions allow for appropriate transit cost management when entering international markets.

Need help with taking a test from R&D to routine manufacture?

Whether you are an established player or emerging innovator, a good lateral flow test contract manufacturer will guide you through the outsourcing process, while being an extra pair of eyes for scoping opportunities and a safety net in supporting success.

Contact Abingdon Health to see how help you on your journey.

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To Outsource or Not Outsource – Is It Really a Question?

Outsourcing Vs. In-House Resourcing – The Guide