ABSTRACT
The 1980s were mostly driven by “Plan for Success.” The industry was focused on navigating the early biotech product candidates through clinical stages to obtain regulatory approval. However, for manufacturing stable biopharmaceutical products, fed-batch cell culture processes have become the dominant platform. Considering the fact that continuous cell culture processes have been used for licensed products for several decades, the main focus of this chapter is on downstream processing platforms that utilize one or more continuous bioprocessing unit operations. Effective process validation is an inherent part of quality assurance for pharmaceuticals. Manufacturing of monoclonal antibodies is performed with the use of mammalian cells and hence there is a risk of unintentionally introducing viruses into the process. During the process design stage, the control strategy for the platform should also be established. During the commercial manufacturing stage, the process is subject to continual validation.
