"I was fortunate enough to attend the Biotech 2013 Single-Use Technology in Biopharmaceutical Manufacturing meeting in Wädenswill, Switzerland in June, Eric Langer of BioPlan Associates stated “That this should be the last meeting on Single Use Systems”. Now whilst I suspect that this will not be the case, his point was really that in the past it has been necessary to champion the cause for Single Use Systems, but we have now reached a point where Single Use Systems are the norm in biopharmaceutical production. To me this is a key point and I think that we should no longer view Single Use Systems from a perspective of being a new and innovative approach, but as a mature technology. There are now few product types that cannot be made in hybrid if not entirely Single Use Systems, and we are increasingly seeing their use for the production of in-market as well as early stage clinical products. Additionally, we are seeing an increased number of facility builds and upgrades based on these approaches.
Unsurprisingly, a number of suppliers have been keen to promote this concept, presenting this as a kind of utopian world, where they are able to provide an entire production facility to the end user. However, not wanting to spoil the party, one has to suggest that some end users may not be entirely keen to share this dream. As the market and use of Single Use Systems moves to a level of maturity, one issue which seems not to be widely discussed is the of cost the consumables for Single Use Systems. When one looks back on the initial business case developed by suppliers for the adoption of Single Use Systems, the cost comparisons were always based on single use vs. fixed plants. Without wanting to be cynical, one might suspect that the initial price modelling was based more on what the market was prepared to pay rather than the actual cost of manufacturing. Since this pricing approach was adopted, we have seen a significant increase in the scale of production but this increase in manufacturing scale hasn’t been matched by obvious reductions in consumable costs and increased competition between suppliers.
In a World where drug manufacturers are being challenged to decrease the cost of drug development and in-market products by improved efficiencies and process productivities competition to drive down consumable costs would be expected. Working for a CMO that makes wide spread use of Single Use Systems, it is quite apparent that customers for early stage products are often alarmed at consumable bills for manufacturing processes which can in some cases be in excess of direct charges; causing not only short term budgetary concerns, but also concerns with regards to long term manufacturing costs of their products. One suspects they are not alone as we are already seeing a number of end users seeking greater levels of connectivity between equipment to allow for systems from different suppliers to be used in manufacturing processes, not only to reduce their reliance on single suppliers, but also to open up more competition into the market place. Whilst this might not be the model the suppliers are working against, it is not unreasonable to suggest that unless there is a more open market place there will be a growing reluctance of end users to accept such high levels of dependence on a single supplier and a slow down in the adoptions of these manufacturing approaches for in-market products."