Biopharmaceutical process development: Part I, Information from the first product generation

This is the first of a series of three papers investigating the development of manufacturing processes for biopharmaceutical drugs. This paper examines what can be learned from the development of the first generation of biopharmaceuticals. Its objective is to review the manufacturing processes used and the times taken to develop a representative range of recombinant proteins - from cloning and expression through to market approval. Conclusions are drawn from comparisons made between the manufacturing processes of modern recombinant biopharmaceutical drugs and their predecessors.