
Single‐use technologies in biopharmaceutical manufacturing: A 10‐year review of trends and the future
Author(s) -
Langer Eric S.,
Rader Ronald A.
Publication year - 2014
Publication title -
engineering in life sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 57
eISSN - 1618-2863
pISSN - 1618-0240
DOI - 10.1002/elsc.201300090
Subject(s) - bioprocess , modular design , scale (ratio) , manufacturing engineering , single use , engineering , manufacturing , systems engineering , risk analysis (engineering) , computer science , process engineering , business , marketing , physics , quantum mechanics , chemical engineering , operating system
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.