Author:
Uhlenbrock Lukas,Jensch Christoph,Tegtmeier Martin,Strube Jochen
Abstract
Traditional extraction processes of natural product are widespread, especially in regulated industries. Possibilities of extraction development and manufacturing optimization in regulated industries is limited. Regulatory approvals are often based on traditional preparations of phyto-pharmaceuticals. The dependence on traditional processes can result in sub-optimal extraction parameters causing unnecessary costs and product variability. Innovative methods like Quality-by-Design (QbD), including process analytical technology (PAT), open opportunities for manufacturers to cope with regulatory demanded, narrow batch-to-batch variability. In addition, such validated process models represent perfect digital twins which could be utilized for advanced process control and life cycle analysis.
Subject
Process Chemistry and Technology,Chemical Engineering (miscellaneous),Bioengineering
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