What are the advantages and challenges of continuous bioprocessing?

Continuous processing maintains steady-state operation with constant feed and harvest. Advantages include: smaller equipment footprint (10x smaller for same annual output), consistent product quality at steady state, reduced capital costs, higher productivity (no downtime between batches), and real-time quality control. Challenges include: complex process control requirements, start-up and shutdown transitions, contamination risk over extended runs, regulatory pathway (batch records vs continuous monitoring), equipment reliability for long campaigns, and process validation complexity. Implementation approaches: fully integrated continuous (all unit operations linked) vs hybrid (continuous perfusion with batch DSP). Perfusion culture, continuous chromatography (MCSGP, SMB), and inline formulation are key enabling technologies.