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Because of their complexity, the new generation of genetically engineered protein drugs can only be made by biotechnological methods, using cultures of animal cells.
This book covers all aspects of the 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 developments in all of these areas and how they all need to be integrated for the design of an effective biotechnological production process. It therefore provides a comprehensive guide to this area of biotechnology. First published in 1994.