Single-use bioprocessing is now common for the production of biopharmaceuticals. Existing and future biopharmaceuticals are extremely complex molecules that display structural heterogeneity. This heterogeneity must be carefully controlled in order to deliver consistently safe and efficacious product to patients. The FDA’s Guidance for Industry on Process Validation states that the manufacturer should understand the sources of variation be able to detect variation and understand the impact of variation on the process and ultimately the product.
This presentation will review sources of bioprocess variation and look at ways in which it can be measured, controlled and monitored through existing technologies. The concepts described will be illustrated using a variety of case studies from existing literature and our experience in sensing and the automation of single-use processes.