What Is Biopharmaceutical?
The term biopharmacology describes a field of research closely related to pharmacokinetics, sometimes called biopharmacy.
Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
The first such substance approved for therapeutic use was recombinant human insulin (rHI, trade name Humulin), which was developed by Genentech and marketed by Eli Lily in 1982.
The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently high-tech pharmaceutical products.
When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications.
Within the United States, the Food and Drug Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks.
The manufacture of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles.
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