Gottschalk, U., Shukla, A. Single-use disposable technologies for biopharmaceutical manufacturing, Trends in Biotechnology, 31(3), 147-154, 2013.
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. Production facilities, until recently, relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. Now, 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 increase the market penetration of disposable manufacturing and improve performance in the future.
The article includes the following highlights:
- Single-use disposable technologies in the manufacturing of biopharmaceuticals
- Advantages and limitations of single-use manufacturing
- Single-use systems for protein drug substance production process: key features, current scales and vendors
- Disposables reduce cost of clinical manufacturing and co-locating manufacturing
Keywords
Single-use manufacturing; Disposables; cGMP
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