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2.3.3.2 Pharmaceutical Applications

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The estimate of about 350 biotechnology drugs currently undergoing development, including vaccines, gene therapy, antisense technology and antibodies derived from “humanized” transgenic mice. Protein engineering was used to produce therapeutic proteins with improved properties such as increased solubility and stability. Many of the early protein drugs derived from biotechnology failed because they were primary molecules with suboptimal affinity or poor half-life in vivo, leading to poor efficacy. In other cases, many of the original protein drug molecules were non-human and caused immune responses against the drug itself. Affinity, half-life and dosing are all interrelated and play a role in determining the clinical efficacy and financial viability of protein-based drugs. This increased understanding of the issues affecting success in drug development was paralleled by increased capabilities in protein engineering and selection/screening technologies. These were used to improve the effectiveness of a number of protein drug candidates.

Biomolecules from Natural Sources

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