Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project plan. However, screening optimal process conditions can be time-consuming and tedious. In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. Employing high-throughput tools for process development helps address these challenges.
High-throughput process development (HTPD) shortens development time at the same time as it increases the amount of information available during early process development. Evaluating chromatographic conditions can be performed in parallel using 96-well filter plates. As a result, a large number of experimental conditions can be evaluated simultaneously. This allows a large experimental space to be characterized and supports the definition of a well-established process design space where process parameters that need to be monitored and controlled are
understood.
This handbook focuses on process development work in PreDictor 96-well filter plates, which are prefilled with chromatography media (resins). The handbook describes how results obtained using PreDictor plates can be used to define process conditions for large-scale chromatography. Applications of PreDictor plates are provided, as well as practical hints and tips. Assist software, dedicated to allow high-throughput methodology using PreDictor plates, is also described.