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Published on: December 15, 2017
Modeling of purification operations in biotechnology: enabling process development, optimization, and scale-up.
Ajoy Velayudhan1, Manoj K Menon
1Purification Development, Centocor R&D Inc., Radnor, Pennsylvania 19087, USA.
Biotechnology Progress
|February 3, 2007
Summary
Process modeling uses mathematical equations to predict and improve biotechnological purification processes like chromatography and filtration. This review highlights industrial applications and recent advances in modeling these critical downstream operations.
Area of Science:
- Biotechnology
- Chemical Engineering
- Process Systems Engineering
Background:
- Process modeling, utilizing mathematical equations to represent physical phenomena, is crucial for predicting process behavior and guiding development.
- While common in chemical industries, process modeling is underutilized in biotechnology purification unit operations.
- Recent FDA guidelines advocate for process modeling, multivariate statistics, and risk assessment in process development.
Purpose of the Study:
- To review recent advancements in process modeling for key downstream unit operations in biotechnology.
- To focus on the industrial applications of modeling in chromatography, filtration, and centrifugation.
- To incorporate relevant findings from recent scientific conferences.
Main Methods:
- Review of recent literature on process modeling in biotechnology.
- Analysis of industrial applications of modeling for downstream unit operations.
- Synthesis of information from scientific sessions, including the American Chemical Society National Meeting.
Main Results:
- Identified key advances in modeling chromatography, filtration, and centrifugation for industrial use.
- Highlighted the growing importance of process modeling in biotechnology, driven by regulatory encouragement.
- Showcased the potential of validated models to predict behavior and optimize process variables with limited data.
Conclusions:
- Process modeling offers significant potential for optimizing biotechnology purification processes.
- Further adoption of modeling in areas like chromatography, filtration, and centrifugation is encouraged.
- Modeling aids in meeting regulatory expectations for process development and risk assessment.
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