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White Paper on Continuous Bioprocessing May 20-21 2014 Continuous Manufacturing Symposium
Konstantin B Konstantinov1, Charles L Cooney2
1Late Stage Process Development, Science, Genzyme-A Sanofi Company, 45 New York Ave., Framingham, MA 01702.
Journal of Pharmaceutical Sciences
|August 1, 2017
Summary
Continuous bioprocessing offers significant advantages for biologics manufacturing, including consistent quality and reduced costs. Addressing current technical challenges is key for widespread adoption of these advanced manufacturing systems.
Area of Science:
- Biotechnology and Biopharmaceutical Manufacturing
- Chemical Engineering and Process Development
Background:
- Growing industrial and academic interest in continuous processing for biologics.
- US FDA encouragement for advanced manufacturing techniques.
- Established benefits of continuous manufacturing: consistent quality, smaller footprint, higher productivity, and cost reduction.
Purpose of the Study:
- To provide a consensus on opportunities and technical needs in continuous bioprocessing.
- To outline strategic directions for implementing continuous bioprocessing systems.
- To review various architectures of continuous bioprocessing.
Main Methods:
- Literature review of existing continuous bioprocessing research.
- Consensus building through input from numerous reviewers.
- Illustrative examples of different continuous bioprocessing system architectures.
Main Results:
- Identified key advantages of continuous manufacturing (sustained operation, consistent quality, reduced equipment size, high volumetric productivity, streamlined flow, low cycle times, reduced costs).
- Highlighted technical challenges that require further research and development.
- Presented a consensus on strategic directions and opportunities for the field.
Conclusions:
- Continuous bioprocessing holds significant promise for the future of biologics manufacturing.
- Further research and development are necessary to overcome existing technical hurdles.
- Strategic implementation and addressing challenges will enable routine adoption of continuous bioprocessing.
