Biomedical Engineering Reference
In-Depth Information
1
The Bioproc
essing Industry—An Introduction
A soul is but the last bubble of a long fermentation in the world.
George Santayana
The discovery of the DNA structure in the middle of the 20th century led
to numerous breakthroughs in biological science and inspired a genera-
tion of entrepreneurs. The 1980s and 1990s saw a booming biotech industry
introducing many biologic products to the market. As with small-molecule
drugs, biologic development faces challenges in long development cycles,
low success rates, and high costs of development that clearly surpass the bil-
lion dollar mark. Despite this financial barrier, the biological drugs industry
continues to thrive; it is anticipated that in the future almost 40% of all new
applications would be for biological drugs.
The 2010 sales of mainly recombinant therapeutic proteins and antibodies
exceeded US$100 B (from $92 billion in 2009 to $108 billion in 2010). Growth
was mainly driven by therapeutic antibodies (+16% to +33% versus the pre-
vious year), which accounted for 48% of biologics sales in 2010. Among the
therapeutic proteins, double-digit growth was reported for insulin and
insulin analogs (+17%) and recombinant coagulation factors (+16%), whereas
modest growth (4% to 7%) was observed for therapeutic proteins, except for
erythropoietin, which continued its descent (−3% versus 2009) and follicle
stimulating hormone (FSH) products (−1%). The anti-TNF biologic etanercept
continued to be the single best-selling blockbuster molecule with 2010 sales
of US$7.287 B. The insulin analog detemir achieved for the first-time block-
buster status, and increased, together with the neurotoxin Botox, the number
of blockbuster antibodies and proteins to 30. Such spectacular growth of bio-
logical drugs also comes with a forecast that in the future more than 40% of
all drugs approved would be derived from biological sources.
The engine for biological manufacturing comes from ever-improving
expression systems, and
Table 1.1
gives examples and their status as of today.
While the barriers to developing new drugs keep getting higher because
of the regulatory demands of assuring safety, the technological barriers to
manufacturing these drugs have certainly come down. The current technol-
ogy can be traced back to the dawn of civilization, through mammalian cell
culture technology—the expression system preferred for most known thera-
peutic proteins with desirable glycosylation patterns—is relatively new. It
took two decades of trials and tribulations to bring cell culture from a bench
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