Mark Simmons

24
Aug

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,

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19
Aug

Lyophilising or Air Drying. Which is better for my assay?

  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

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17
Aug

Re-defining the limits of single batch assay stabilisation

  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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23
Jul

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

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8
Jul

How lyophilised reagent beads increase assay accuracy and speed to result

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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27
Jun

Why partner with a contract manufacturer?

  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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30
Mar

How lyophilised reagent beads can reduce waste

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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25
Mar

Welcome to the team Megan, Ish and Georgina

  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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17
Feb

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

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3
Feb

Biofortuna supports World Cancer Day

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