The efficient and safe delivery of therapeutic proteins is the key to comme
rcial success and, in some cases, the demonstration of efficacy in current
and future biotechnology products. Numerous delivery technologies and compa
nies have evolved over the past year. To critically evaluate the available
options, each method must be assessed in terms of how easily it can be manu
factured, impact on protein quality, bioavailability, and toxicity. Recent
advances in depot delivery systems have, for the most part, overcome all of
these obstacles except for complex and costly manufacturing. On the other
hand, pulmonary delivery usually involves efficient manufacturing, but low
protein bioavailability resulting in higher doses compared with injections.
Although recent advances in transdermal and oral delivery have been signif
icant, both of these delivery routes require logarithmic increases in bioav
ailability to make them viable candidates for commercialization. In the nex
t few years, protein delivery for commercial products will probably be limi
ted to injection devices, depot systems and pulmonary administration.