Beyond the next generation of therapeutic proteins

摘要

This article describes a major paradigm shift in the development of therapeutic proteins, from a second generation of products that are based on engineering or modification of the native molecule to a third generation which can be delivered orally. Therapeutic proteins are one of the most important and rapidly growing segments of the pharmaceutical market, with estimated annual world-wide sales of over 35 billion dollar in 2005. However, the producers of these first generation protein drugs currentlyface a number of important problems, including patent expiries on several blockbuster products and competition from small molecule alternatives and biogenerics. This, as well as the need for improved clinical performance (e.g. less frequent injection and new routes of administration), and improved product life cycle management has motivated the development of so called 'next generation' products based on the engineering or modification of the native molecule.