High Throughput Process Development

A biopharmaceutical production process involves many processing steps that all have to be sized and operated correctly to achieve to a product that can meet strict criteria as put forward by regulatory agencies like e.g. the US Food and Drug Administration FDA. Designing such a process is finding an optimum in a multi‐dimensional parameters space. Traditionally such processes were developed with a combinations of heuristics and lab scale experimentation, leading to long devolvement times and considerable use of material and ultimately suboptimal processes. Nowadays in industry, lab scale experimenting has been replaced by High Throughput Screening (HTS) or High Throughput Experimentation (HTE) approaches using robotics, reducing consumables and development time considerably. The field is coined High Throughput Process Development (HTPD). This presentation will show the evolution of HTPD, where next to experimentation also mathematical modeling and process simulation emerge, as well as further miniaturization attempts. Examples will be shown for typical downstream bio separation operations.