Biomedical Engineering Reference
In-Depth Information
13
EVOLUTION AND INTEGRATION
OF QUALITY BY DESIGN AND
PROCESS ANALYTICAL
TECHNOLOGY
Duncan Low and Joseph Phillips
13.1 INTRODUCTION
Biotechnology has delivered some of the most significant advances in medical technol-
ogy over the past 25 years. From the licensing of the first recombinant proteins in 1981,
through the development of monoclonal antibodies, fusion proteins, gene therapy,
transgenic animals and plants, stem cell technology, and now the creation and selection
of completely novel molecules through techniques such as molecular evolution and
phage display, the degree of innovation has been remarkable. More importantly, the
contributions to patient survival, quality of life, and eventual cure has been, and continues
to be, a source of great pride and motivation to our industry.
In contrast, the extent to which the pharmaceutical industry has incorporated
advances and improvements in manufacturing technology has been considerably less
adventurous. It seems that any degree of innovation and creativity can be applied to the
creation of new candidate molecules, but once those molecules are recognized as
having potential, without any deleterious side effects, any change to the molecule or
the process by which it is made is viewed as a regulatory hurdle and an opportunity
for failure rather than an opportunity for continued improvement and refinement.
