Hi, I’m Nick, and I’m the Operations Manager here at Biofortuna.

Today the team and I are finishing one of our largest lyo bead manufacturing runs to date – this time for an assay designed to detect salmonella.

While this particular assay is for a food safety application, the technology you will see today is essentially the same across a range of applications, including point of care clinical diagnostics and animal health.

Behind me, you can see we are preparing to remove just over 200,000 beads that have been in the freeze dryer for just coming up to 36 hours.

And in many ways, I find this the most rewarding part of my role as I get to see the hard work we have put into the development process really pay off with a seamless transfer into commercial manufacture.

But the truth is, to get to this stage, the real work started some time ago.

Whenever we can, we like to start working with our customers as early as possible in the assay design stage. In this case, the customer already had an established wet assay on the market and they wanted to produce a lyophilised version to be manufactured as a bead.

Lyophilised products obviously have a much longer shelf life than a wet assay and reduce the expense and environmental impact of cold chain.

But lyophilising as a bead also delivers greater accuracy in terms of dosage volume and speed of reconstitution, while also significantly reducing the risk of contamination and wastage.

Working with our clients early gives us the opportunity to ensure that their formulation is optimised for lyophilisation.

The first stage of that process involves establishing the ideal freeze drying conditions of the assay using a technique called freeze drying microscopy. FDM allows us to observe the crystallisation and collapse temperature of the formula so we can determine the effect of the excipients such as cryoprotectants and stabilising agents on the final product.

Once we have a formulation that is optimised for lyophilisation, we can begin to scale up.

Dispensing and lyophilisation takes place in our ISO seven clean room.

But before we start, it’s essential to ensure that the dispense pump pressures, bead sink rates, and cycle speed are all optimised for the specific formulation we are working with. Because ultimately, even the best equipment is only as good as the expertise and the attention to detail of those operating it.

Throughout the process we gravimetrically measure dispense volumes to ensure we are delivering the consistency our customers demand to allow them to develop best-in-class assays and take them to market quickly and efficiently.

And that brings us up to where we are now.

Today’s batch of 200,000 beads coming out of free dry number four, ready to go through a strict quality control process where we will test critical parameters such as residual moisture content, size, and bead hardness.

We have put together an application note which gives more information on the yield, precision and accuracy of two recent 200,000 dispense runs which you can download using the link to the right of this case study.