Biopharmaceuticals and pharmaceutical biotechnology

Terms such as 'biologic', 'biopharmaceutical' and 'products of pharmaceutical biotechnology' or 'biotechnology 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 definition 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

Pharmaceutical biotechnology: concepts and applications Gary Walsh © 2007 John Wiley & Sons, Ltd ISBN 978 0 470 01244 4 (HB) 978 0 470 01245 1 (PB)

Table 1.1 Some traditional pharmaceutical substances that are generally produced by direct chemical synthesis


Molecular formula

Molecular mass

Therapeutic indication

Acetaminophen (paracetamol) Ketamine Levamisole Diazoxide Acyclovir Zidovudine Dexamethasone

Misoprostol Cimetidine

C8H9NO2 C13H16C/NO









237.74 204.31 230.7 225.2 267.2 392.5

382.5 252.3


Anaesthetic Anthelmintic Antihypertensive Antiviral agent Antiviral agent Anti-inflammatory and immunosuppressive agent Anti-ulcer agent Anti-ulcer agent to the use of biological systems (e.g. cells or tissues) or biological molecules (e.g. enzymes or antibodies) for/in the manufacture of commercial products.

The term 'biopharmaceutical' was first used in the 1980s and came to describe a class of therapeutic proteins produced by modern biotechnological techniques, specifically via genetic engineering (Chapter 3) or, in the case of monoclonal antibodies, by hybridoma technology (Chapter 13). Although the majority of biopharmaceuticals or biotechnology products now approved or in development are proteins produced via genetic engineering, these terms now also encompass nucleic-acid-based, i.e. deoxyribonucleic acid (DNA)- or ribonucleic acid (RNA)-based products, and whole-cell-based products.

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