Biomedical Engineering Reference
In-Depth Information
Pharmaceuticals, biologics
and biopharmaceuticals
1.1 Introduction to pharmaceutical products
Pharmaceutical substances form the backbone of modern medicinal therapy. Most traditional phar-
maceuticals are low molecular weight organic chemicals (Table 1.1). Although some (e.g. aspirin)
were originally isolated from biological sources, most are now manufactured by direct chemical
synthesis. Two types of manufacturing company thus comprise the 'traditional' pharmaceutical sec-
tor: the chemical synthesis plants, which manufacture the raw chemical ingredients in bulk quanti-
ties, and the fi nished product pharmaceutical facilities, which purchase these raw bulk ingredients,
formulate them into fi nal pharmaceutical products, and supply these products to the end user.
In addition to chemical-based drugs, a range of pharmaceutical substances (e.g. hormones and
blood products) are produced by/extracted from biological sources. Such products, some major
examples of which are listed in Table 1.2, may thus be described as products of biotechnology. In
some instances, categorizing pharmaceuticals as products of biotechnology or chemical synthe-
sis becomes somewhat artifi cial. For example, certain semi-synthetic antibiotics are produced by
chemical modifi cation of natural antibiotics produced by fermentation technology.
1.2 Biopharmaceuticals and pharmaceutical biotechnology
Terms such as 'biologic', 'biopharmaceutical' and 'products of pharmaceutical biotechnology' or 'bio-
technology medicines' have now become an accepted part of the pharmaceutical literature. However,
these terms are sometimes used interchangeably and can mean different things to different people.
Although it might be assumed that 'biologic' refers to any pharmaceutical product produced
by biotechnological endeavour, its defi nition is more limited. In pharmaceutical circles, 'biologic'
generally refers to medicinal products derived from blood, as well as vaccines, toxins and allergen
products. 'Biotechnology' has a much broader and long-established meaning. Essentially, it refers
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