1. Continuous Processing in Upstream Operations
This article discusses the evolution of mammalian cell cultures, as well as the pros and cons associated with fed-batch processing. It also provides an overview of perfusion.
2. Continuous Processing in Downstream Operations
Downstream processing (DSP) of biologics includes clarification, capture, purification, polishing, and preformulation. This sequence applies to products that are secreted by cells into a culture media, such as a monoclonal antibody, which is the current dominant form of biologic product. This article describes and details the downstream processing sequence, as well as discusses the major obstacles to overcome for commercial implementation.
3. Regulatory Considerations in the Development of Continuous Manufacturing Processes for Biological Pharmaceuticals
Continuous manufacturing is an emerging issue in the pharmaceutical industry that the U.S. Food and Drug Administration (FDA) has identified as a priority area in its Strategic Plan for the Regulatory Sciences. The FDA recognizes and supports the development of progressive manufacturing strategies, such as continuous manufacturing. Technical and business hurdles to implementation remain, but they are not related to regulatory differences between continuous and batch processes. The FDA expects industry sponsors to provide a risk-based, data-driven alarm/control strategy that assures stable and reproducible processing.