Selecting the right contract manufacturer for in vitro diagnostic assays: your 12-point checklist

Increased throughput, improved efficiency, reduced risk

There are many reasons you might consider a new assay manufacturing partner. You may need to ramp up production quickly to meet increasing demand, or you could be looking to reduce production costs. Perhaps you want to mitigate the risk of a single source of supply, or perhaps an issue with an incumbent supplier has exposed a weakness in your supply chain.

Other common challenges include:

  • unpredictable demand spikes
  • 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 your supply chain.

Whatever the reasons, selecting the right contract manufacturer is a complex decision, and one that is not without its own risks. You will need to find a partner that understands your business, offers the flexibility you require and has the capacity and quality accreditations in place to meet your needs.


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How the right contract manufacturer can help

A good contract manufacturer will work with you to understand your challenges. They will be able to provide solutions based on the core principles of:

  • expertise and experience – enabling you to mitigate risk and increase output
  • openness and transparency – a genuine partnering approach designed to solve your problems and build a lasting relationship
  • flexibility – with the capacity to deal with large scale production and fluctuating demand.


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

Your 12-point checklist for selecting a contract manufacturer

  1. Do they have the expertise and experience to meet your requirements quickly and with reassuring confidence?
  2. Is their workforce sufficiently skilled?
  3. Do they have the manufacturing capacity to meet your production schedules and the flexibility to cope with sudden changes in production requirements?
  4. Do they have modern and efficient manufacturing facilities that guarantee quality, consistency and security of supply?
  5. Can they provide small-scale pilot batch manufacturing and trial sizes?
  6. Do they have the correct certifications and accreditations?
  7. Do they offer triple-batch validation to ISO 13485?
  8. Will they provide a secure and dependable audit trail for each batch?
  9. Do they have state-of-the-art temperature and humidity-controlled (down to 5%) clean rooms?
  10. Are they based in the correct geographical location to shorten your supply chains and reduce your logistics costs?
  11. Do they offer greater security, lower risk and better value than your existing suppliers?
  12. Can they provide the full range of outsourced services you need to rationalise your supply chain?


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
  • ISO and FDA quality accreditations
  • Logistics – we are able to hold 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.


Get expert technical advice. Contact us now.

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