22 Biotechnology Products

and Development

David A. ShapiroandAnthony W. Fox

22.1 Introduction

The objectives of this chapter are to describe what
biotechnology products are, and where their regu-
lation is similar or different from chemically
synthesized, small molecule drugs. It is a common
assumption that biotechnology has sprung from
nothing,de novo, within a small number of recent
years. This is not the case, and we shall show how
the recent growth of this field actually has a basis
which is, in many ways, common and intercon-
nected with development of all other types of
drugs. We shall also explore, briefly, how the
science of pharmacogenomics interfaces with the
development of biotechnology products.

22.2 Definition

Biotechnology products are those that are prepared
using biological organisms, rather than the usual
types of industrial chemical synthesis. Biological
organisms may be usedin vivo, ex vivoorin vitroto
make these products.
Biotechnology products are diverse, including
polypeptides, biological organisms themselves
(living, dead or attenuated), genes, any type of

fermented product (even when these may be alter-

natively synthesized chemically) and antisense

compounds. To date, the peptides have formed

the largest group among these, themselves being

functionally very diverse: hormones, antibodies,

cytokines (including interferons) and immune

adjuvants (including nonmammalian examples,

such as Key-hole Limpet (Megathura crenulata)

hemocyanin).

Biological products have a longer history than is

generally assumed. At one time small pox

accounted for 10% of deaths in some countries.

The development of cow pox vaccination in 1796,

and later theVariocellavaccine, has led to small

pox being the only infectious disease ever to have

been eradicated from the planet; the final outbreak

was after a laboratory accident in 1979, leading to a

small number of cases.

It is beyond the scope of this chapter to discuss

all potential applications and all present techno-

logies associated with biological drugs. We wish to

concentrate here on the newer technologies that are

actually used on either an investigational or

approved basis in human beings, and can only

provide an overview. Thus, vaccines, fermented

antibiotics, blood products, diagnostic products

(e.g. antibody-based assay systems) and devices

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9