This book covers all aspects of the new technologies needed to turn animal cells into an acceptable and cost-effective tool for drug production. This includes modifying them genetically so that they produce the right product in high yield, getting them to grow reproducibly on an industrial scale, and extracting the required product from them. It also covers biological safety issues, and the verification of the chemical and biological nature of the protein drug produced. The work covers the latest developments in all of these areas and how they all need to be integrated for the design of an effective biotechnological production process.
Table of Contents
1. Introducing the animal cell as a bioreactor; 2. Yield of recombinant product: engineering cells for maximum expression; 3. The generation of biomass, medium design for animal cell culture, fermenter design for animal cell culture, suspension cultures, immobilized cells, process control; 4. Adjusting cellular metabolism for optimum product yield; 5. Downstream processing; 6. Regulatory aspects of using cells as bioreactors, viral contamination of animal cell derived pharmaceuticals; 7. Overview and conclusions; References; Index.