Biotechnology Manufacturing

Aim

The course gives the students an overview of the field and give them experience in solving engineering tasks of process analytical and process design character. Focus is on manufacturing of biologicals. Training and written reporting using adequate engineering terminology. Good understanding for principles of process analytical technology concepts (PAT) and quality by design (QbD) aspects on manufacturing.

Content

Design and simulation methodology for industrial biotechnical production processes. Focus on pharmaceutical products. Training in culturing protein producing organisms and use of advanced monitoring and control techniques; design tool software programming; mathematical modelling of key design issues. Analytical methods for cultivation and in-process control. Regulatory quality guidelines for biotechnology manufacturing.