The classical separation of development (pre-marketing) and production (post-marketing) does not work for biologics, since both the manufacturing process and plant are factors that determine quality of the final medicinal product.
. Production is the basis for long-term market supply. Decisions about capital investment or outsourcing of manufacturing mostly have to be taken long before the market launch of the product.
. Biotechnological processes are much more difficult to control than small-molecule preparations. The limited ability to monitor and characterize the product results in increased manufacturing risks.
kicks in, taking care of a high-quality and profitable product supply, addressing the following main tasks:
. When, where and in which quantities should the drug be produced? (Production concept.) . How should market supply be organized? (Supply-chain organization.) . How should the quality of the product and Good Manufacturing Practice (GMP) compliance be assured? (Quality assurance.) . What are costs of manufacturing and how can these costs be controlled? (Manufacturing costs.) . How attractive is an investment in ones own facilities? (Investment decision.)
The marketing of the product stands at the end of the value chain; from this position, essential goals are formulated for production: supply safety and cost efficiency.
The integrated position of production in the value chain results in interdisciplinary tasks that are best treated in multilateral teams attended by experts in different disciplines like biology, engineering, chemistry, economics, law, pharmacy or medicine.
Figure 1.2 shows the subject areas that are important for the understanding and control of production processes and workflows. This volume provides an overview over these subject areas, while special emphasis is given to the interaction between these areas.
Following this introductory Part, Part Two, Technology, focuses on process and analytics. This section illustrates why the manufacturing process plays such a large role in biotechnology, and to what extent product quality is determined by processes and analytics. Moreover, essential technologies for industrial manufacturing are described as well as methods and areas of application of analytical testing.
Part Three, Pharmacy, briefly elaborates on the basic principles of drug effects in humans and the essential steps of pre-clinical and clinical drug studies. The successful end of the clinical test marks the starting point of commercialization.
Product quality plays a crucial role in pharmaceutical manufacturing. Part Four, Quality Assurance, elucidates the organizational and operative workflows for quality assurance, including the rules of GMP.
Almost all activities of commercial production happen in the framework of legal regulations. Part Five, Pharmaceutical Law, describes drug regulations and laws as well as institutions and enforcing official authorities.
The translation of process technology into large-scale manufacturing capacities is described in Part Six, Production Facilities. Basic principles of the design of GMP-compliant manufacturing facilities are given and different building concepts compared. The planning process that leads to industrial plants is illustrated. Here, we include a brief look Production is interdisciplinary 1.1 Role of Production in Pharmaceutical Biotechnology j5 From lab to large-scale process Validation and critical parameters Role of analytics Production facilities