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Cultivation of Mammalian Cells Using a Single-use Pneumatic Bioreactor System
Published on: October 10, 2014
Single-use disposable technologies for biopharmaceutical manufacturing.
Abhinav A Shukla1, Uwe Gottschalk
1KBI Biopharma, Durham, NC, USA. ashukla@kbibiopharma.com
Trends in Biotechnology
|November 27, 2012
Summary
Single-use technologies are transforming protein biopharmaceutical manufacturing, moving away from traditional stainless steel equipment. Continued advancements promise improved performance and wider adoption of disposable systems in the future.
Area of Science:
- Biopharmaceutical Manufacturing
- Chemical Engineering
- Process Technology
Background:
- Traditional biopharmaceutical production relies on inflexible, hard-piped stainless steel equipment.
- Current Good Manufacturing Practice (cGMP) standards govern protein biopharmaceutical manufacture.
- Upstream and downstream processing involve multiple unit operations.
Purpose of the Study:
- To provide a perspective on the current state-of-the-art in single-use technologies.
- To highlight trends in disposable manufacturing for biopharmaceuticals.
- To discuss areas requiring further improvement in single-use systems.
Main Methods:
- Review of current single-use technologies in biopharmaceutical manufacturing.
- Analysis of trends impacting the performance and market penetration of disposable systems.
- Perspective on the evolution of end-to-end single-use manufacturing facilities.
Main Results:
- Single-use technologies offer increased flexibility compared to traditional equipment.
- Technical advancements enable end-to-end single-use manufacturing facilities.
- Several aspects of single-use technology are continuously evolving and require further development.
Conclusions:
- Single-use manufacturing is a growing trend in the biopharmaceutical industry.
- Further improvements in single-use technology will enhance performance and market adoption.
- Disposable manufacturing offers a viable alternative to traditional bioprocessing equipment.
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