ABSTRACT
The biotechnology operation focuses on the development of a specific product. Biomanufacturing planning begins early in the product development cycle and is based on the exact understanding of the product’s nature and intended use or indication. Quality by design is a concept applied to all product development endeavors in biotechnology and is a critical and early aspect of biomanufacture. Biomanufacturing design and planning are greatly impacted by affordable biomanufacturing technologies available for a given type of product and process. Biomanufacturing is a relatively new field, which has expanded, by quantitative and qualitative measures, rapidly. Like any other manufacturing endeavor, biomanufacturing requires raw materials, which are sometimes referred to as components. The discussion on biomanufacture shifts from general subject matter to focus on various biotechnology products and the technologies used to manufacture those products. Chromatographic methods are used in most biomanufacturing purification schemes that involve molecular purification.
