Four tips to mitigate the risk of single source IVD assay manufacturing

How secure is your assay manufacturing?

Manufacturing in vitro diagnostic (IVD) assays in-house, or outsourcing to a single contract manufacturer, should result in the seamless integration of technology transfer, pilot batch production, validation and verification, regulatory submission and subsequently efficient large-scale output. After all, if all those processes are managed in one place the surely there is tighter control?

But a single point of manufacture can also be a single point of failure. How confident can you be that your current operation is robust enough to cope with potential risks and can ensure critical continuity of supply?

There are four key risks that could be hiding within your current assay manufacturing processes:

  1. Inability to manage demand spikes
  2. Long term profitability issues
  3. Continuity of supply vulnerability
  4. Lack of proactivity.

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1. Inability to manage demand spikes

In a perfect world, demand is linear and simple to forecast. However, the reality is often different.

How quickly and how well can your existing manufacturing processes cope with sudden surges in demand? Do you have access to the facilities, the equipment and the experienced people needed to significantly increase assay production at short notice?

And If those demand spikes are irregular and difficult to predict, can you scale down as quickly as you can scale up?

A market-leading contract manufacturer will be experts in resource management. They will have the additional capacity and skilled people available to deploy when, and only when, you need them.

They will offer the flexibility to manage fluctuating demand.  If your current manufacturing methods don’t offer you that flexibility, then it is time to look at other options.


Read here why it pays to partner with a contract manufacturer.


2. Cost/profitability issues

Companies operating at the uppermost limits of their production capacity or from outdated facilities may be more expensive pro rata than bigger, more efficient contract manufacturers.

The largest and most agile operators will utilise their own economies of scale to offer their clients a more efficient manufacturing base – whether they need to outsource their entire manufacturing operation or just a single process.

Together with their technical expertise this provides assay developers with benefits throughout the product life cycle, from increasing speed to market through flexible pilot batch sizes and scale up, to extending the life of legacy products and freeing up in-house capacity for other products.

More efficient manufacturing, easier management, faster speed to market. Can your existing processes still compete? Or is your manufacturing proving expensive and affecting the profitability of your products?


3. Security of supply vulnerability

One of the biggest hidden risks with a single source of manufacturing (if it’s not the right single source), is a break in the continuity of supply.

It’s only hidden until it happens, and then the consequences can be anything from a short-term loss of revenues to far reaching contractual disputes.

The best contract manufacturers will have contingency built into their planning. They will have robust supply chains with their suppliers 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.

Even if you are currently outsourcing to a credible contract manufacturer, diversifying your risk across two manufacturing partners is possibly the most comprehensive way of managing that risk.



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4. Declining proactivity

The final hidden risk, whether you are manufacturing in-house or using a single contract manufacturer, is the risk of becoming entrenched in a comfort zone.

Are your in-house team or supplier still as keen and incisive as they once were? Do they still suggest how to improve your processes, how to benefit from greater efficiencies or the latest new developments?

The best contract manufacturers will always be looking to suggest efficiency improvements and bring new technologies to the table. They will be constantly looking to deliver more value for their customers.

Even if you are relatively happy with your in-house team or incumbent supplier, introducing a new manufacturing partner into the process not only mitigates the risk of a single point of failure in your manufacturing process, it will also generate fresh ideas.

Whatever your manufacturing process, it’s important that efficient for your whole organisation, not simply the most convenient for the manufacturing team. Consider all the costs:  time, quality, management, people and risk. If its not the best fit overall, it’s time to consider a change.


See Biofortuna's manufacturing process in this infographic

Challenges overcome through contract manufacturing

These are the most frequent and pressing assay production challenges that developers face:

  • limited capacity to scale (either in-house or with their existing contract manufacturer)
  • unpredictable demand spikes
  • risk to continuity of supply
  • limited capacity (either in-house or with an incumbent manufacturer)
  • the assay is new to market and needs to move to large scale production quickly
  • the assay is approaching end-of-life and can no longer be manufactured in-house efficiently
  • the need to move some production of the assay closer to a specific geographical market
  • the need to rationalise their supply chain.

Why Biofortuna for contract manufacturing?

Biofortuna works with:

  • biotech start-ups/spin-offs looking to take their first assay from concept to reality
  • established developers looking for the most efficient manufacturing base
  • top-tier global biopharma groups working on the next generation of assays

We deliver our services to three key principles

  • expertise and experience – enabling you to mitigate risk and increase throughput
  • openness and transparency – a genuine partnering approach designed to solve your problems and build a lasting relationship
  • flexibility – from trial batch sizes to large scale production and fluctuating demand

Benefit from a more secure supply chain. Get consistent, high quality contract manufacturing of assays – in the batch sizes and time frames you need.

All delivered from new state-of-the-art facilities in the UK.

  • Capacity to manufacture 10 million reactions per week
  • 450m³ of class-leading, humidity controlled clean room environment
  • ISO 17025, ISO 13485, FDA registration

Get support tailored to your exact requirements. With our problem-solving mentality, we listen to precisely what you need and provide the solution to match.


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