title: Single-use disposable technologies for biopharmaceutical manufacturing.
abstract: The manufacture of protein biopharmaceuticals is conducted under current good manufacturing practice (cGMP) and involves multiple unit operations for upstream production and downstream purification. Until recently, production facilities relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. However, there is an increasing trend towards the adoption of single-use technologies across the manufacturing process. Technical advances have now made an end-to-end single-use manufacturing facility possible, but several aspects of single-use technology require further improvement and are continually evolving. This article provides a perspective on the current state-of-the-art in single-use technologies and highlights trends that will improve performance and increase the market penetration of disposable manufacturing in the future.
authors.affiliation: KBI Biopharma, Durham, NC, USA. ashukla@kbibiopharma.com
authors.forename: Abhinav A
authors.initials: AA
authors.lastname: Shukla
authors.forename: Uwe
authors.initials: U
authors.lastname: Gottschalk
mesh_terms: D001688:Biological Products / Q000302:isolation & purification* / Q000378:metabolism*; D001709:Biotechnology / Q000379:methods* / Q000639:trends; D004209:Disposable Equipment / Q000706:statistics & numerical data* / Q000639:trends; D006801:Humans; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends
chemical_list: D001688:Biological Products