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3. New Directions in Manufacturing and Delivery
Pages 21-26

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From page 21...
... Recent advances that have improved manufacturing and delivery include development of · large-scale, controlled cultivation of animal and plant cells; · efficient production of therapeutic proteins and first generation systems for their controlled delivery; · more effective methods for synthesis of new and more complex pharma21
From page 22...
... . MANUFACTURING CHALLENGES The challenges to the manufacturing process arise from the increasing cost of R&D, the need to develop information systems that exploit benefits from genomics and bioinformatics, pressure on pricing and fierce competition in the industry, the relatively inefficient output of new products due to failure in clinical trials, technical barriers for targeted delivery, and the crude ability to control complex biological processes such as cellular differentiation and organization.
From page 23...
... Another biomanufacturing challenge is the production of organized tissues using tissue engineering. While processes to produce tissue-engineered skin have been commercialized, it is clear that the economic viability of these manufacturing processes must be improved.
From page 24...
... By changing the spacing between the units, one could spread out active agent over some larger volume in the brain, being careful not to get the sources too far apart leaving regions untreated. This is another opportunity to match drug delivery systems with imaging science.
From page 25...
... With DNA for example, a microelectrode in the material can be used to create a local voltage difference which then modulates the rate of release of the drug from the material: drug releases fast when the voltage is on and slow when the voltage is off. One of the advantages of this overall approach using microelectronic materials—is that the drug delivery system can be easily combined with a probe that senses local conditions, either local conditions of voltage or chemistry, allowing release of a drug in response to that local condition.
From page 26...
... Oral delivery for proteins requires stabilizing the protein while it passes through the stomach followed by selective uptake through the gastrointestinal tract and into systemic circulation. While some success has been observed (e.g.


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