July 16, 2019
Dan Stanton, editor, BioProcess Insider
technologies (SUTs), exploring the biopharmaceutical industry’s uptake of SUTs and placing that in context of a current forecasting conundrum. Twenty years ago, the demand for cell culture capacity exceeded available supply, and that played a large role in generating investment into biomanufaturing capacity over the following two decades. In 2002, biological blockbusters were emerging, yet the industry was slow to respond. Demand outstripped capacity, leading to large investments into building up the latter.
Between 2002 and 2006, global bioreactor cell culture capacity grew from 400,000 L to 2.2 million L. This resulted from a huge investment made in a very short period of time. Stanton provided examples of companies that expanded their facilities to meet increased manufacturing demand. However, the global economic crisis of 2009, coupled with patent issues and a dramatic increase in the size of titers, caused the landscape to change. As a result, many companies were forced to adopt new strategies.
Over the past decade, SUT has been adopted increasingly by the biopharmaceutical industry. The benefits are clear: reduction in costs (including those related to energy and water use), increased productivity and time savings, lowered cross-contamination risk, and improved flexibility that allows multiple products to be made in a single facility with smaller footprints and lower capital expenditures relative to what traditional multiuse equipment requires.
However, commercial prospects for SUTs are not unlimited. The biggest challenge to full commercial implementation relates to scale. Back in 2002, expression titers were under a gram of protein per liter of culture; now the industry has been surpassing double-digit titers in g/L. In addition, industry demands have shifted. When personalized or orphan drugs come into play, for example, the sheer volumes assumed for earlier biologic blockbusters will not be as necessary as originally thought.
Safety elements also are a concern. Problems of extractables and leachables have been addressed through industry cooperation: Both the Bio-Process Systems Alliance (BPSA) and the BioPhorum Operations Group (BPOG) are working with regulators, the industry, and suppliers to produce a set of standards and quality testing processes. The more SUT has been used over the past decade, the more confident the industry has become in using the technology, especially in late-stage and commercial production.
In addition, single-use equipment can be expensive. However, the more SUTs are being used, theoretically the more economies of scale should come into play — which should lower the cost of the systems. But continuing consolidation of suppliers could reduce competition among them and might provide them opportunities to pass reduced costs to end users.
SUT also has coincided with a growing outsourcing trend. Contract manufacturing organizations (CMOs) are leading the way in adopting and embracing such technologies. Over the past several years, CMOs have made substantial investments in broadening their single-use capabilities. With SUT, new companies can enter the biomanufacturing space, take up a large market share, invest in doubling facilities at a reduced cost, and make that volume available for industrial use.
Looking beyond 2020, there’s still a great deal of uncertainty regarding supply and demand as new therapeutic modalities come into play. The industry might need to reduce biomanufacturing capacity because some upcoming products are curative and thus won’t require a regular regimen. Will new blockbusters come along to combat diseases that affect large potential patient populations? If so, the industry will need greater capacity to feed that demand.
Ultimately, the use of SUTs means that the industry can be much more responsive to those changing needs.
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