ABSTRACT
This chapter addresses a few additional regulatory considerations that have an impact on the construction of plants for the manufacture of mammalian cell-derived products. Although there are many manufacturing topics which are deserving of consideration, there are a number of specific issues which are likely to arise during the design and construction of a mammalian cell culture plant for the production of therapeutic products which are somewhat problematic. While regulatory considerations are important in establishing some of the broader aspects of plant design and construction, the major influences on many basic performance and construction specifications are often process-driven. In mammalian cell culture, this frequently distills down to a few key factors related to the technology, namely, handling of medium and serum, equipment and facility design, and potential for biohazards. Frequently, the major considerations related to the design and construction of a pharmaceutical plant derive from the basic choices made by the management of the company regarding its field of interest.
