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11:01
Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids
Published on: September 25, 2016
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White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium
Konstantin B Konstantinov1, Charles L Cooney
1Late Stage Process Development, Science, Genzyme- A Sanofi Company, 45 New York Ave., Framingham, MA, 01702.
Journal of Pharmaceutical Sciences
|November 25, 2014
Summary
Continuous bioprocessing offers significant advantages for biologics manufacturing, including consistent quality and reduced costs. Further research is needed to address challenges for routine implementation of these advanced manufacturing systems.
Area of Science:
- Biotechnology
- Chemical Engineering
- Pharmaceutical Manufacturing
Background:
- Growing interest in continuous processing for biologics manufacturing.
- Encouragement from US FDA guidance and active research.
- Continuous manufacturing offers benefits like consistent quality and reduced costs.
Purpose of the Study:
- Provide a consensus on opportunities and technical needs for continuous bioprocessing.
- Outline strategic directions for implementing continuous bioprocessing systems.
- Discuss various architectures of continuous bioprocessing.
Main Methods:
- Literature review.
- Input from industrial and academic researchers.
- Analysis of existing continuous bioprocessing architectures.
Main Results:
- Continuous bioprocessing offers sustained operation with consistent product quality.
- Advantages include reduced equipment size, high volumetric productivity, and lower costs.
- Technical challenges require further investigation for routine implementation.
Conclusions:
- Continuous bioprocessing presents significant opportunities for biologics manufacturing.
- Addressing technical challenges is crucial for widespread adoption.
- Further development and strategic planning are essential for realizing the full potential.
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