New medicines from industry

Autor: Bryan S. Finkle
Rok vydání: 2007
Předmět:
Zdroj: Journal of Chemical Technology & Biotechnology. 43:313-327
ISSN: 1097-4660
0268-2575
Popis: There is a considerable history of natural and biosynthetic biologics used as drugs, and their development, evaluation, and regulation serves as a useful guide to the risks and safety of recombinant drugs in the context of medicine. These agents are human gene products or their analogs, and like traditional pharmaceuticals, have the potential for toxicity. They are purer and better characterized, have a known spectrum of bioactivity, but they are not to be assumed safe because they are components of natural self. The reality is they have their own risk-to-benefit ratios. They are made by very complex, large-scale biochemical engineering capable of producing very pure product, but with the possibility of greater variation than occurs in small organic molecules synthesized by medicinal chemistry methods. Many toxicology position papers have been published, but no firm guidelines have yet been established by Government Regulatory Agencies. At present, it is the combined judgment of the toxicologist, pharmacologist, and clinician that determines the rational progress of a protein (drug) from the gene to patient. This long, difficult journey in which toxicology plays such an important part can be illustrated by the development of human growth hormone and tumor necrosis factor, the former a recombinant product to replace a natural hormone extracted from human tissue, and the latter a previously unavailable cytokine with poorly defined biological effects, for the treatment of selected cancers. The history, hard work and hope for these and other protein drugs presents a clear story of how benefit-to-risk can be studied and understood.
Databáze: OpenAIRE
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