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Automation of Dead End Filtration: An Enabler for Continuous Processing of Biotherapeutics
- Source :
- Frontiers in Bioengineering and Biotechnology, Vol 8 (2020), Frontiers in Bioengineering and Biotechnology
- Publication Year :
- 2020
- Publisher :
- Frontiers Media SA, 2020.
-
Abstract
- Dead end filtration is a critical unit operation that is used for primary and secondary clarification during manufacturing of both microbial and mammalian cell based biotherapeutics. Dead end filtration is conventionally done in batch mode and requires filter pre-sizing using extensive scouting studies, along with filter over-sizing before deployment to handle potential variability. However, continuous manufacturing processes require consistent use of dead-end filtration over weeks or months, with potential unpredictable variations in feed stream attributes, which is a challenge currently facing the industry. In this work, a dead-end filtration skid is designed for continuous depth filtration, incorporating multiple small-sized filters along with turbidity, and pressure sensors with immediate switching to a fresh filter whenever turbidity or pressure breakthrough above a pre-determined cut-off is detected in real time. The skid has been successfully tested for manufacturing of granulocyte colony stimulating factor from Escherichia coli, human serum albumin from Pichia pastoris, and a monoclonal antibody therapeutic from CHO cells. The proposed skid can be directly applied for any dead-end filtration application with minimal prior scouting studies or sizing calculations for scale-up. It is a useful solution for continuous processing trains where the nature of the feed, such as its turbidity or host cell proteins content, may change over long continuous campaigns, rendering previous sizing calculations inaccurate. The skid also allows significant cost savings by eliminating the sizing safety factor of 1.5–2x which is generally added before filter deployment at manufacturing scale.
- Subjects :
- 0301 basic medicine
Histology
Computer science
lcsh:Biotechnology
turbidity breakthrough
Biomedical Engineering
Bioengineering
02 engineering and technology
continuous bioprocessing
law.invention
03 medical and health sciences
depth filtration
law
lcsh:TP248.13-248.65
Process engineering
Filtration
Original Research
Dead end filtration
business.industry
Bioengineering and Biotechnology
021001 nanoscience & nanotechnology
Unit operation
Automation
Pressure sensor
Sizing
pressure breakthrough
030104 developmental biology
Skid (automobile)
Filter (video)
Batch processing
0210 nano-technology
business
Biotechnology
Subjects
Details
- ISSN :
- 22964185
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Frontiers in Bioengineering and Biotechnology
- Accession number :
- edsair.doi.dedup.....0970c27fc4a51fd239016b1d3029c46a