Blog

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

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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

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  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

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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

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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

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  Developing a new assay that will ultimately find commercial success is notoriously complex. To that effect, managing your manufacturing processes in-house may initially appear to be the most streamlined and snag-free route to market. After all, what could benefit your production cycle more than having everything under one roof, ready for immediate analysis, testing and shipping? In reality, overseeing

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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

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  Megan, Ish and Georgina are the latest cohort of Laboratory scientists to join us as we continue on our strategic growth journey that will see us become one of the world’s largest and most agile assay contract manufacturers. In November of last year,  we announced our relocation into a new, purpose built manufacturing facility and our intention to double

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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

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