Developing new products and processes is increasingly a focal point of competition and often requires the development and successful implementation of novel process technologies. The process development and production of a new discovery (new biological entity) are significantly more complex than for the production of small molecule drugs or new chemical entities. Conventional new product development models in the literature on firm level innovation do not capture the evidence we present on development projects for pharmaceuticals. This paper shows why a new perspective is required to understand the management of product and process development for biopharmaceuticals and proposes an explanatory model for this purpose.