Single-use technologies are now dominant for the clinical production of biopharmaceuticals and are becoming more mainstream within commercial manufacturing facilities. They allow biologics manufacturers to decrease the footprint of their facilities by approximately 20% because of a reduced need for utilities that generate water, steam, and clean-in-place solutions. Engineers believe that the capital outlay for a single-use facility is 25–45% less than for a facility based on stainless steel equipment. Similarly, they estimate that such facilities need half the water and energy during operations and can be constructed in as little as 18 months. That is in contrast to the three years it can take to get a stainless steel facility up and running. Furthermore, the risk of product cross-contamination between batches is considerably reduced.
Biomanufacturers must be able to trust single-use technology as they implement it into increasingly critical bioprocessing process steps and applications. We have seen evidence that a single bag failure can cost manufacturers between US$100,000 and $1 million and that, each year, leaks in single-use systems have resulted in the loss of product valued at up to $20 million. Changes to the raw materials used in production of single-use systems must be analyzed by biopharmaceutical producers, a process that can cost €100,000 per change. What is worrying for process scientists is increasing evidence to show that some single-use materials are biologically active. A recent study by the DECHEMA society for chemical engineering and biotechnology showed that 7 out of 11 readily available bags on the market inhibited or interfered with cell growth.
The industry must address four key challenges that biomanufacturers face when developing a single-use system: It needs to ensure that the technology does not interact with living cells or biological products, that it is a closed and integral system, that it does not leak, and that its supply is ensured. Finally, such systems must reduce complexity, improve quality, and minimize the burden of change controls through standardization. The solutions to these challenges are interrelated, but they depend on improving control of raw materials, components, and processes within the supply chain.