ABSTRACT
As biotechnology has moved from research and development to the production and marketing of biopharmaceutical products, greater emphasis on quality assurance (QA) and validation of the processes used has occurred. In most biotechnological systems, the objective is a specific protein or group of proteins. From a QA perspective, the protein(s) must be identifiable, of high purity, and reproducible. Potentially contaminating entities, such as viruses, endotoxins, mycoplasmas, and denatured product must be eliminated or inactivated. Concurrently, analytical methods must be developed to identify and quantitate the active constituent(s) and identify the absence of contaminants. This book presents a series of selected topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address some of the quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product.
