Across the industry, Blackfield Associates is witnessing a wave of change in the on-site infrastructure of pharmaceutical manufacturing: the switch from traditional stainless steel vessels and bioreactors to the nu-school of single-use systems. What has prompted this change? What are the advantages (or disadvantages) of making the move? And, more importantly, what effect does this have on the industry? Blackfield’s specialist consultant Jack Belcher has been investigating.
Efficiency – a key consideration
First and foremost, the keyword, central to the discussion, is efficiency. In basic terms, during upstream bioprocessing, ingredients must pass through several stages in order to be fully processed into an Active Pharmaceutical Ingredient (API), which can then be developed into a usable pharmaceutical product. Bioreactors are an essential part of this process. The overall pipeline of production will be massively affected by the time between batches on the upstream side. With stainless steel vessels, the time it takes to clean, even with Clean in Place (CIP) systems installed, is orders of magnitude longer than the time it takes to replace bags in a single-use system. There is an even greater margin in multi-product facilities where cross-contamination is a concern.
On the other hand, anecdotally, we have found that problem-solving and continuous maintenance of stainless steel systems is easier. Engineers and contractors of ours have reported that the larger parts and more expansive construction make it easier to pinpoint and resolve issues.
Supply capacity and cost
There are also problems with the supply of these single-use bags across the many companies that are adopting the process. However, this could mostly be due to the rapid change seen across the market. In the US, the industry is already seeing a single-use adoption rate of ≥85% at the pre-commercial scale As these systems become the norm, and other producers step in to plug the gaps, this issue will be less and less of a concern.
We see a much different picture at the larger, commercial (more than 2,000L), size with 92% of bioreactors globally being stainless steel vessels. Interestingly, 55% of these stainless steel bioreactors are more than 10,000L in scale. This is a massive swing, and numbers like these really help us to see the use-case for each system.
Small-scale, single-use bags are efficient, economically viable, and convenient, however they simply cannot compete at the larger volumes. In fact, the mechanisms to take on these larger batches simply do not exist.
Alongside this, cost is of course a consideration. In every viable circumstance, the purchase of single-use bags are cheaper than the capital expenditure involved in the procurement and installation of stainless steel bioreactors. Outside of installation costs, on average, single use systems cost around $10,000 per unit (bag), with a lifecycle of one batch per unit. In comparison, stainless steel bioreactors can only be priced by facility, with a six-vessel facility (6x 2,000L reactors) coming in at $200 million. The lifecycle of such a system is around 10 years on average (these figures do not represent operating and maintenance costs, or the costs of CIP systems needed for the stainless steel approach). Potential adopters of each system would need to weigh up these costs and lifespans to arrive at the most appropriate conclusion. However, on the surface, it appears that Single-Use systems favour smaller CAPEX facilities and projects.
Still a place for each
Overall, it can be said that both systems have their place in the market and, despite what suppliers may have you believe, there is no risk of one superseding the other. For pre-commercial, multi-product facilities, single-use systems are king. However, at the opposite end, where products are mass-produced at batch-scales much greater than 2,000L, there is simply no replacement for traditional steel.
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