Ten reasons to outsource assay manufacture

If you have always manufactured your in-vitro diagnostic (IVD) assays in-house, it’s tempting to stick with what is tried and tested.

After all, it has worked up until now, and in theory manufacturing in-house should result in the seamless integration of development, validation, regulatory submission, and subsequent large-scale output. And if all those processes are managed in one place, then surely there is tighter control?


However, there are many reasons you might consider outsourcing some or all your assay manufacturing. Partnering with a proven, well-resourced contract development and manufacturing organisation (CDMO) could help you take advantage of new opportunities without the risk of large-scale capital investment.


The drivers for change

The most common drivers for diagnostic developers to reassess their manufacturing arrangements are:


1 – The assay is new to market and needs to move to large scale production quickly

The diagnostics world moves quickly. If you have developed an assay that can improve the accuracy, availability, or affordability of diagnostic testing, then large-scale market penetration is paramount.  Not only for the benefit it brings in terms of patient outcomes, but also to realise your return on investment in a fiercely competitive market.

There is a real risk that the innovation of the developer that is first to market is lost to the rival that can manufacture and distribute more efficiently.

Working with a large, CDMO gives you the flexibility to quickly scale up production.


2 – Limited capacity

Partnering with a flexible contract manufacturer allows diagnostic companies to increase production incrementally in line with demand, avoiding the need for large scale capital investment.


3 – New market opportunities

Assay developers need to be fleet of foot to be able to capitalise on new market opportunities. For example, the current focus on point of care testing (POC) presents real opportunities for companies marketing products that reduce the time to result cost-effectively.

However, maximising those opportunities often requires a detailed understanding of the latest manufacturing technologies and sufficient capacity.  A contract manufacturing partner can provide both.


4 – Unpredictable demand spikes

In a perfect world, demand is linear and easy to forecast. However, the real world is subject to a host of external market forces, which can make demand unpredictable.

A large contract manufacturer will have the capacity to cope with unexpected surges in demand such as the recent COVID-19 pandemic, and the flexibility to even out those demand spikes by adjusting production levels accordingly.


Read our COVID-19 case study


5 – Risk of continuity of supply

One of the biggest risks with exclusively manufacturing in-house is a break in the continuity of supply. The best contract manufacturers will have contingency built into their planning. They will have robust supply chains and crucially they will be agile enough to redeploy resources as and when required.

Having the latest state-of-the-art equipment, regularly tested, and validated, will make the risk of technical failure exceptionally low, but even should it occur, there will be a backup available to ensure uninterrupted supply.


6 – The need to move some production to a specific geographical market

Sometimes the driver for change can be as simple as a requirement to move some production to be closer to its market, for any number of environmental, economic, legislative, regulatory or logistical reasons.


7 – The assay is approaching end-of-life and can no longer be manufactured in-house efficiently

If demand for a legacy product starts to decline, it may no longer be profitable to manufacture in-house. Sometimes the continued production of a legacy product can also hamper the development of newer, potentially more profitable products by restricting resources.

The largest and most agile operators will utilise their own economies of scale to offer their clients a more efficient manufacturing base. It’s quite possible that an assay that is struggling to deliver the required margins when manufactured in-house could do so if production is switched to a more agile contract manufacturer.


8 – Supply chain rationalisation

If current manufacturing is spread across several geographical sites or contractors, switching production to a single, larger contract manufacturer would be likely to significantly reduce costs and shorten the supply chain.


9 – Removing the barriers to new product development

There are significant risks with developing a new assay. It may work as a concept, but the risks associated with commercial manufacture, such as additional capital investment and the recruitment of additional, suitably experienced staff, may make the project unfeasible.

Partnering with an experienced contract manufacturer can mitigate those risks.


10 – Embracing new technologies

Utilising new technologies can deliver step-change improvements in patient outcomes.

However, embracing new technology requires expertise and capacity. Whether it’s a new stabilisation technique such as single dose reagent beads or the large-scale manufacturing experience required to turn a concept into a cost-effective reality, partnering with a contract manufacturer allows you to buy in the expertise and capacity you require.


 Find out more about Lyophilised beads


Why choose Biofortuna as your contract manufacturer?

 Expertise, risk mitigation, flexibility and accelerated speed are the four key benefits you will get from partnering with Biofortuna.

We help assay developers to secure their supply chains with consistent, high quality contract manufacturing – at the batch sizes and in the time frames they need. All delivered from new state-of-the-art facilities in the UK.

  • Large production capacity available now
  • Flexible batch sizes
  • ISO13485 and FDA quality accreditations
  • Logistics – we can securely store and ship stock
  • Extensive expertise and experience.

Our support is tailored around your exact requirements and defined by a problem-solving mentality. We listen to precisely what you need and find the solution to match.

A combination of technical expertise, ISO 13485 and ISO 17025 accreditation, FDA registration and leading-edge facilities mean you can rely on the highest scientific standards when bringing your products to market.


Any questions? – Ask an expert

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