"In my last Pharma IQ blog ahead of the Disposables Solutions meeting in Munich next month, I said that I would be looking a two key areas, which would feature in the discussion sessions during the meeting, the first being flexible facilities which I covered in that blog, the second being the drivers behind the adoption of single use systems, which I will cover in this blog.
From my perspective the drivers behind the adoption of single use systems should be viewed on multiple levels, and in the context of a number of other changes which are occurring within the Biopharm industry and are having a profound impact on the attitude companies are taking to investments in manufacturing facilities.
A number of cost models have been set up and run for, or against, the adoption of single use systems. These initial models tried to predict break points for the benefits of single use systems over fixed plant, as I recall the break point was around the 1000L. So it was not surprising that when Hyclone (now Thermo Fisher) announced that they were producing a 2000L SUB, the move was met with scepticism and belief that they would never sell any systems. However what we see now is end user’s buying this scale of SUB in significant numbers and suppliers looking at further increase the scales of these systems. This then begs the question what are the current drivers for the increased adoption of these manufacturing approaches.
Whilst the significantly reduced initial investment costs, shorter payment times and lower fixed overheads associated with single use systems are a huge drivers, in the decision making process, it seems to me that there are other factors at play here. One of these is clearly the increased productivity levels that have been achieved in recent years, especially in the field of antibody production. The other seems to be changes that are occurring within development groups, the disease targets they are addressing and the impact this will have on future clinical development and in-market requirement.
It often seems to me that the understanding of future market requirements is an area which is all too often disconnected from discussions on bio-manufacturing. Whilst, predicting future market needs is always challenging, however there are a number of trends that are emerging. One of these is the much greater interest in niche market products within large Pharma, as well as smaller companies, and the move away from developing Blockbusters. This suggests that the need for very large product quantities of specific products will decline in future for new clinical entities and, when combined with increased productivities, will significantly drive down potential manufacturing scales.
The second is that companies are increasingly looking to improve development costs and timelines as well as in-market manufacturing costs, and companies are increasingly open to outsourcing these activities to CMO’s in order to achieve these goals. For these companies, return on investment is essentially based on predicted levels of facility occupancy and tight control of operational overheads. When this is combined with the potential need to adapt to a broader range of manufacturing processes and production scales, the switch to small more flexible facilities based around single use systems becomes a compelling proposition; even if this results in consumable costs, with limits on manufacturing scales and decreased levels of process intensification."
Pharma IQ: Making Tomorrow's Medicines