Upstream Single - Use Bioprocessing Systems

S ingle-use bioprocessing equipment has become wellaccepted technology in a relatively short time. Disposable devices and components have created market niches and new segments that continue to evolve. In this dynamic environment, it is diff icult to measure acceptance or assess market growth. Here we project the world market for cell culture single-use systems (SUS) as well as problems affecting that market, including adoption for commercial manufacture. This is based on our 10-year analysis of the industry, with data from our eighth annual survey report on biomanufacturing (1). Complex SUS devices with unique attributes continue to emerge. The first single-use bioreactors — Wave rocker platforms (now from GE Healthcare) — entered the market just about 10 years ago. The disposable-bioreactor market remains dynamic, with new entrants and variants continually being tested as alternatives to stainless steel for commercial applications. Single-use technologies (SUTs) now make up a large percentage of smalland midscale biopharmaceutical manufacturing, particularly in clinical testing and research and development (R&D). Upstream SUT includes disposable bioreactors, mixers, containers, tubing, connectors, sampling systems, purification devices and columns, and probes/sensors. Almost all such equipment, particularly the critical parts that contact process streams, is composed primarily of various types of polymers (“plastics”). Market value estimations and the number of devices sold are both moving targets. By now, the industry is well aware that SUTs provide many economic and other advantages over f ixed stainless-steel systems, with companies on average spending about US$1 million/year on disposable equipment (1). Even assuming comparable overall costs, SUTs offer compelling advantages over stainless steel. Greater f lexibility allows companies to buy and assemble systems as needed and store them on site for future use. Those advantages have resulted in SUT capturing a majority of the market for new bioreactors in smallscale research and clinical supplies manufacturing. However, new disposable equipment needs to be purchased for each product run/lot manufactured. No matter the scale, even at ≥2,000 L, SUTs involve cycles of equipment one-time use, disposal and replacement. So although up-front, operating, and total costs are generally lower for SUTs than stainless steel, recurring expenses will be higher because of regular repeated purchases (whereas stainless steel equipment is purchased and installed once). Although SUT dominates much of biopharmaceutical R&D already and is emerging in clinical-scale segments, biopharmaceutical manufacturing is currently dominated by mammalian cell culture capacity, use, and expenditures, especially for monoclonal antibodies (MAbs) that require repeated large doses. Currently, disposable devices have not entered mainstream commercial manufacturing, partly for regulatory reasons. When regulatory agencies approve broad use of plastic singleuse devices, the total market for such devices will increase significantly.