ABSTRACT
This book discusses the product development pathways for all types of biotechnology products. It describes in detail the development pathways for all products derived from the medical, agricultural, environmental, industrial, and nanobiotechnology sectors. One of the basic requirements of any biotechnology product is to make a business plan, which includes work on the novel and economically feasible project. In product development terms, quality is a relative term that is defined by how well the product meets or exceeds what it was designed to do. One of the most important components of biotechnology product development is to set up the infrastructure required to manufacture the biotechnology products based on the good laboratory practice or good manufacturing practice requirements and as per Food and Drug Administration guidelines. In much of the industrialized world, the history of medicinal product registration has followed a similar pattern, which could be described as an initiation, acceleration, rationalization, and harmonization.
