Product and Process Innovation in the Development Cycle of Biopharmaceuticals

Purpose The biopharmaceutical market has shown continuous growth under the intensive focus of the pharmaceutical industry. The processes for R&D and production of biopharmaceuticals are significantly more complex compared to those associated with small-molecule drugs. The complex structures of protein molecules make achieving successful development while meeting quality requirements challenging. We aimed to elucidate differences in patterns of product and process innovations between the biopharmaceutical and chemical-based pharmaceutical industries.