Disposable bioprocessing: The future has arrived

• Published in: Biotechnology and bioengineering Vol. 102; no. 2; pp. 348 - 356
• Main Authors: Rao, Govind, Moreira, Antonio, Brorson, Kurt
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-02-2009; Wiley; Wiley Subscription Services, Inc
• Subjects: Biological and medical sciences; Biosensing Techniques - methods; Biotechnology; Biotechnology - instrumentation; Biotechnology - trends; Cell Culture Techniques - instrumentation; Cell Culture Techniques - trends; Digital signal processors; Disposable Equipment - standards; Disposable Equipment - trends; disposable technology; Equipment Design; Fundamental and applied biological sciences. Psychology; PAT; process consistency and validation; QbD; scale-up; Sensors; Validation studies; Waste disposal; Dimensioning; Disposable; Validation; PAT; QbD; process consistency and validation; Detector; sensors; Technology; scale-up; Operating process; disposable technology
• ISSN: 0006-3592; 1097-0290
• DOI: 10.1002/bit.22192

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.