Latest News

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

Read more

Whether you are lyophilising or air drying your assay, your ultimate goal is to stabilise it for transport and storage at ambient temperature without loss of functional performance. Get expert advice on freeze drying and air drying Both processes involve the removal of water to achieve this and enable you to: eliminate the need for cold chain storage extend shelf

Read more

  In response to increasing demand for stabilised molecular diagnostic assays, we have significantly increased our single batch lyophilised reagent bead manufacturing throughput to 300,000 reactions per freeze drying run and are now progressing towards a capacity of 100 million tests per annum. Utilising bespoke high precision automation, four dedicated freeze driers (each with 3.5m2 shelf capacity) housed in a

Read more

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

Read more

What are lyophilised reagent beads? Lyophilised reagent beads are durable spheres of freeze-dried material formed from accurately measured dispense volumes of customisable formulation. These single-dose beads – like lyophilised cakes – retain long-term stability at ambient temperature and therefore do not need expensive cold chain shipping or refrigeration during storage. This significantly increases the accessibility of diagnostic testing for difficult-to-reach

Read more

What are lyophilised reagent beads? Lyophilised reagent beads are durable spheres of freeze-dried material formed from accurately measured dispense volumes of customisable formulation. These single-dose beads – like lyophilised cakes – retain long-term stability at ambient temperature and therefore do not need expensive cold chain shipping or refrigeration during storage. This significantly increases the accessibility of diagnostic testing for difficult-to-reach

Read more

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

Read more

We are proud to support the UICC’s World Cancer Day initiative

Our scientific and marketing teams have just completed the finishing touches on our latest whitepaper which outlines the principle benefits of using lyophilised reagent beads to stabilise in vitro diagnostic assays. The 24 Page document explains how the single dose nature of a bead delivers benefits in dosage consistency, speed of reconstitution and reduced risk of contamination and wastage, as

Read more

Biofortuna (Deeside UK), a specialist contract development and manufacturing partner to the IVD and point of care testing sectors, has more than doubled its manufacturing capacity following its relocation to new state-of-the-art facilities in Deeside, North Wales.   The purpose-built facilities have been designed by the Company to provide the most efficient and modern manufacturing laboratories from which to meet

Read more