A PSE approach for yield enhancement in bioprocessing
by Technion Israel Institute of Technology
Improving the sigma level of a pharmaceutical process leads to reduced cycle times and increased overall efficiency and quality. These objectives can be achieved using an approach involving process analytical technology (PAT), Six Sigma methodology, process modeling and advanced process control and statistical process control. This methodology is demonstrated on a simplified process for the production of penicillin including a fermentor and the first of the downstream processing steps. This white paper, from Technion IIT, shows that a combination of improved process control in the downstream processing sections as well as a modified substrate feeding profile in the fermentor, can together achieve a 40 percent reduction in batch time while significantly increasing throughput yield.
In the pharmaceutical industry, the purification process is important since an unpurified product cannot be marketed. In contrast, however, the overwhelming majority of activity published in the literature has focused on the study of reaction or fermentation, rather than in the downstream processing. More effort could be invested to improve operations in downstream processing, or better yet, to take a plantwide stance in the design and optimization of the process.
| Published: | 2005 |
| Format: | |
| Length: | 4 pages |
| Type: | White paper |
| Language: | English |
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