Challenges in Commercial Biotechnology. Part II. Product, Process, and Market Development

Abstract

Publisher Summary The development process begins after the complete discovery of the product. This is a very lengthy, expensive, and tightly regulated process. Pharmaceutical companies spend much of the product development conducting clinical trials required to pass the safety, efficacy, and quality requirements of the drug, followed by the FDA review and approval. Product development also includes pharmaceutical development of dosage forms and formulations. In parallel with product development, process development is carried out. In microbial process biotechnology, it may start at the time of product discovery, when a new microbial product is available and when an appreciable amount of product is needed for chemical characterization. The technical development is expanded when a compound is more advanced and enters more extensive biological and preclinical test. Further process improvements and scale-up are needed for clinical tests and as the production decision is near. In addition, market development begins with the cost/benefit analysis, grows with product innovation, and peaks with capturing a substantial share of market.