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Disposable bioprocessing: The future has arrived
Author(s) -
Rao Govind,
Moreira Antonio,
Brorson Kurt
Publication year - 2008
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.22192
Subject(s) - bioprocess , context (archaeology) , biopharmaceutical , biochemical engineering , process engineering , process (computing) , computer science , scale (ratio) , manufacturing engineering , engineering , microbiology and biotechnology , biology , paleontology , physics , quantum mechanics , chemical engineering , operating system
Increasing cost pressures are driving the rapid adoption of disposables in bioprocessing. While well ensconced in lab‐scale operations, the lower operating/ validation costs at larger scale and relative ease of use are leading to these systems entering all stages and operations of a typical biopharmaceutical manufacturing process. Here, we focus on progress made in the incorporation of disposable equipment with sensor technology in bioprocessing throughout the development cycle. We note that sensor patch technology is mostly being adapted to disposable cell culture devices, but future adaptation to downstream steps is conceivable. Lastly, regulatory requirements are also briefly assessed in the context of disposables and the Process Analytical Technologies (PAT) and Quality by Design (QbD) initiatives. Biotechnol. Bioeng. 2009;102: 348–356. © 2008 Wiley Periodicals, Inc.