Protein-based therapeutics biopharmaceutical industry

As the biotechnology industry comes of age, and protein-based therapeutics become a practical reahty, the importance of protein-stabilizing technologies comes increasingly to the fore. The therapeutic efficacy of many of these biopharmaceuticals is impeded by the hosts natural immune defense system [23]. When a host encounters a foreign protein in its circulation, the hosts immune system initiates an immune response, which results in the production of protein-inactivating antibodies that dear the protein from the circulation. When the immune system develops an abihty to inactivate the protein, the therapy becomes ineffective. Hence, to counteract... 

In the last two decades, CE has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrument-based method for micro-scale separation, but has also emerged as an indispensable tool in the biotech and pharmaceutical industries (Chapter 14). CE has become a method of choice in R D for molecular characterization, and in QC for release of therapeutic biomolecules. In the biopharmaceutical industry, more and more CE methods have been validated to meet ICH requirements. To demonstrate the influence of CE in RScD for method development and in manufacturing for the release of therapeutic proteins and antibodies, examples from the pharmaceutical industry are provided in Chapter 14. 

The amount of vaccine or therapeutic protein produced in a plant can reach industrial-scale levels. The typical yield of biopharmaceuticals produced in a plant-based system is 0.1%-1.0% of total soluble protein (Twyman et al., 2003). This value is competitive with other expression systems therefore, a plant expression platform for biopharmaceuticals is economically viable. As an example, one bushel of maize can produce as much avidin as one ton of chicken eggs but at 0.5% the cost. 

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