Considerable effort and time is allocated to introducing cell culture and fermentation technology to undergraduate students in academia, generally through a range of courses in industrial biotechnology and related disciplines. Similarly, a large number of textbooks are available to describe the appli- tions of these technologies in industry. However, there has been a general lack of appreciation of the significant developments in downstream processing and isolation technology, the need for which is largely driven by the stringent re- latory requirements for purity and quality of injectable biopharmaceuticals. This is particularly reflected by the general absence of coverage of this s- ject in many biotechnology and related courses in educational institutions. For a considerable while I have felt that there is increasing need for an introductory text to various aspects of downstream processing, particularly with respect to the needs of the biopharmaceutical and biotechnology ind- try. Although there are numerous texts that cover various aspects of protein purification techniques in isolation, there is a need for a work that covers the broad range of isolation technology in an industrial setting. It is anticipated that Downstream Processing of Proteins: Methods and Protocols will play a small part in filling this gap and thus prove a useful contribution to the field. It is also designed to encourage educational strategists to broaden the coverage of these topics in industrial biotechnology courses by including accounts of this important and rapidly developing element of the industrial process.

Includes supplementary material: sn.pub/extras

Klappentext

Mohamed A. Desai and a team of experienced biotechnologists review both conventional and novel isolation techniques used in industrial applications for the downstream processing of protein molecules. These techniques include primary and secondary separations during the isolation of biomolecules, as well as unique laboratory-scale research methods from academia with a potential for scale-up. Also treated are various strands of the downstream biological process essential for a successful product license application, including both the validation of DSP stages, and the design and validation of viral clearance stages during the purification process. Downstream Processing of Proteins: Methods and Protocols provides scientists everywhere, but particularly in the biopharmaceutical and biotechnology industry, with a much-needed introduction to this critical technology.

Inhalt
Downstream Processing in the Biotechnology Industry.- 2 Microbial Cell Disruption by High-Pressure Homogenization.- 3 Protein Concentration and Buffer Exchange Using Ultrafiltration.- 4 High-Performance Tangential Flow Filtration for Protein Separations.- Large-Scale Recovery of Protein Inclusion Bodies by Continuous Centrifugation.- Application of Density Gradient Ultracentrifugation Using Zonal Rotors in the Large-Scale Purification of Biomolecules.- Application of Chromatography in the Downstream Processing of Biomolecules.- Affinity Ligand Technology.- Immunoaffinity Adsorption in the Large-Scale Isolation of Biomolecules.- Expanded Bed Adsorption in the Purification of Biomolecules.- Application of HPLC in the Purification of Biomolecules.- Countercurrent Chromatography of Proteins with Polymer Phase Systems.- Practical Aspects and Applications of Radial Flow Chromatography.- Sterile Filtration and Virus Filtration.- Design and Interpretation of Viral Clearance Studies for Biopharmaceutical Products.- Validation of Sterilizing Filters in the Biotechnology Industry.