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What Is Drug Manufacturing?

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  • Written By: T. Broderick
  • Edited By: Heather Bailey
  • Last Modified Date: 28 February 2019
  • Copyright Protected:
    2003-2019
    Conjecture Corporation
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Drug manufacturing is the end result and key goal of the pharmaceutical industry. The physical creation of a drug comes only near the end of a long process that may involve millions of dollars and years of research. The process begins with research scientists testing the effectiveness of chemical compounds on a variety of diseases. If preliminary tests show positive results, animal and human testing follow. If a drug is approved for widespread use, a drug manufacturer develops a cost-effective way to mass produce the drug.

The drug manufacturing process begins with research labs, most owned and operated by pharmaceutical companies, testing a variety of new and existing compounds on a host of diseases. In the testing of a new antibiotic, for example, a scientist might swab the drug onto many Petri dishes, each containing a different bacteria. The result of these first rounds of testing determine whether the drug can move on to the next step. Even if the antibiotic in question is ineffective, it is still possible that a future researcher may discover a more beneficial use for the drug.

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After a drug shows promise in a controlled laboratory setting, animal and/or human testing begins. Animal testing is preferred if scientists have concerns about side effects. Human testing is a long process where researchers and patients are put into double blind studies: neither patients nor scientists know which patients receive the drug and which receive a placebo. One double blind trial, such as for an experimental HIV vaccine, can take more than a year to accomplish. As many trials are necessary before a drug can come up for review by a national drug approval agency, drug testing can take up to and beyond a decade to accomplish.

Once a drug manufacturer has shown that its drug is effective in human trials, it recommends its drug to a national drug approval agency. In the United States, this agency is the Food and Drug Administration (FDA). After a pharmaceutical company files an application with the FDA, the FDA runs its own clinical tests on human patients. If the results match with the pharmaceutical company's findings, the drug is approved for use in the United States.

Once a drug is approved for commercial use, a pharmaceutical company must still develop an economical method of drug manufacturing. This process may involve buying new equipment or building a new factory to produce the drug on a mass scale. Once everything is in place, drug manufacturing can begin. In most facilities, drug manufacturing is mainly an automated process, from the mixing of chemical compounds to having the product bottled, labeled and shipped to pharmacies worldwide.

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