| Abstract: | The ability to observe biological interactions in real‐time using optical biosensor technology provides the scientist/engineer with a valuable analytical tool to analyze biological molecules. Production of biological products is a growing area, but the course of discovery through to production is lengthy and complex, especially for therapeutic products. However, the economics of developing new products are clear, time to market for a new product is the primary consideration. Limited patent lifetimes, the need to get a return on the investment in research and gain competitive advantage by launching products before competitors all contribute to the necessity to get products to market. The ability of biosensor technology to give rapid, direct information on key biological parameters, (such as product concentration), makes it a suitable analytical tool to help accelerate the development of biological products. It is difficult to conceive how direct measurements of this speed and selectivity can be possible with other analytical methods. This paper aims to describe how this potential can be brought to use from biological product conception and discovery all the way through to process operation and quality control. |
