Single‐use bioprocessing equipment has made considerable progress in the past 10 years. These devices now dominate small‐ and mid‐scale bioprocessing and are starting to graduate to larger scale manufacturing. We now have nearly a decade of combined industry experience covering the benefits of single‐use vs. fixed stainless steel. Single‐use systems are generally recognized as enabling rapid setup of bioprocessing at multiple scales in the same manufacturing area. A decade ago there were significant unknowns and concerns about single‐use equipment. Today, these plastics and equipments have much improved, and include advanced design, multilayer laminated plastic bags, and other integrated technologies. This article reviews bioprocessing single‐use systems market characteristics and trends over the past decade and forecasts future developments. Much of this grounded and based on data from the annual survey of bioprocessing professionals conducted by BioPlan Associates, Inc., now in its 11th year. In addition to quantitative survey data, this annual report includes extensive discussion and external analysis of bioprocessing and related trends. This article also includes data from other primary research resources. Single‐use and modular systems are making capacity crunches increasingly unlikely; in fact, estimating current and projected industry capacity may become subjective and possibly irrelevant.

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his article documents the progress, current state, and projected future trends in titer and yield as industrial and technological benchmarks for commercial-scale biopharmaceutical manufacture. Biopharmaceutical product commercial-scale manufacturing (bioprocessing) was benchmarked by tracking titers and yields over time, from the 1980s to the present, and further out ten years. This study compiled commercial-scale titer and yield data for a set of 39 major biopharmaceuticals, nearly all mammalian-expressed proteins, particularly, monoclonal antibody products. This included extensive searches of many potential data sources, including contacting knowledgeable bioprocessing professionals. In the 1980s and early 1990s, average titers at commercial scale started out at < 0.5 g/L. The current average reported commercial-scale titer is 2.56 g/L. We also confirmed that the manufacture of commercial products has, over the years, undergone repeated cycles of technical production upgrades, with titers and yields increasing incrementally, even for the oldest products. BioPlan estimates that ≥3 g/L is now the industry standard titer for new bioprocesses being developed, with ≤7 g/L now presumed to be the general industry top-end titer level that, while not unusual, is not often achieved. In terms of yields, we found a 70% yield to be the current industry average yield, not the often-cited 75%. Improvements in downstream purification technologies (e.g., as demonstrated by higher yields) have been fewer and adopted more slowly than upstream production.