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Genetech - Essay

Genetech

Robert Swanson and Dr. Herbert Boyer founded Genentech on April 7, 1976. In it�s beginnings, Genentech pioneered a new scientific field called Recombinant DNA technology. The two young men and their company faced criticism from academic communities and businesses. Ignoring the cruel comments, they kept moving forward with each new daring step. Genentech is old in age compared to other biotechnology and bioscience companies, but not in cutting age breakthroughs. A year after their debut to the world the first human protein (somatstatin) in a microorganism (E. Coli bacteria) was produced. If there was no respect for Genentech before, there was now. The talk of diseases, disorders, and ...

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FDA gives approval to market the products in the United States (other countries have analogous regulatory agencies). Genentech received over 15 FDA approvals from 1985 to 1999. FDA approval is based on the official data resulting from Genentech�s clinical trial system. The system is divided into three phases (refer to Products). The first is Phase I clinical trials which are designed to examine the safety of the drug. The drug is administered to human participants who are closely scrutinized for the smallest indication of harm caused by the medicine. Further trials and development cannot take place unless Phase I trials show the drug to be safe. Genentech is currently planning Phase I clinical trials of AMD Fab, a fragment of an anti-VEGF antibody, for potential treatment of age-related macular degeneration. In this condition, abnormal blood vessel growth in the retina of the eye can lead to blindness.
Phase II clinical trials are designed to confirm safety, determine ...

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Genetech. (2008, November 11). Retrieved November 28, 2024, from http://www.essayworld.com/essays/Genetech/92892

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"Genetech." Essayworld.com. November 11, 2008. Accessed November 28, 2024. http://www.essayworld.com/essays/Genetech/92892.

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PAPER DETAILS

Added: 11/11/2008 08:34:47 AM
Category: Economics
Type: Premium Paper
Words: 822
Pages: 3

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