edited by Roshni L. Dutton
An increasing number of pharmaceuticals in human and veterinary medicine are being developed using advanced genetic and other methods that focus on modification of somatic and embryonic cells. These methods, in the setting of drug manufacture, call for new processes that go beyond the traditional unit processes of chemical and biological production, e.g., fermentation.
Advanced Technologies in Biopharmaceutical Processing is the first to describe in detail these advanced biological processes and show how they are applied to the production of biopharmaceuticals, from product generation and purification to finish-fill operations.
The work explains how technologies developed in the last decade function similarly to unit processes for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic cells--to name a few.
From large-scale animal cell bioreactors to patient-customized products, Advanced Technologies in Biopharmaceutical Processing describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process development.
Contents
1. Overview of the Biopharmaceutical Industry
2. Regulatory Requirements for Processing Biopharmaceuticals
3. Genomics, Proteomics, and Metabolomics – Impact on Biopharmaceutical
Processing
4. New Technologies in Biopharmaceutical Upstream Processing
5. New Technologies in Biopharmaceutical Downstream Processing
6. Biopharmaceutical Product Formulation, Preservation, and Presentation
7. Biopharmaceutical Product and Process Monitoring, Analysis and Control
8. Discrete Automation in BioProcessing Unit Operations
9. Emerging Biopharmaceutical Platforms
Index
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