CHARACTERIZATION AND PROCESS VERIFICATION STUDIES IN A MINIATURE BIOREACTOR USED AS A PREDICTIVE TOOL TO SCALE-UP AN INDUSTRIAL PROCESS

摘要

There is continuous pressure on the pharmaceutical industry to acquire a thorough understanding of their product and process, using a quality by design (QbD) approach, in order to speed up the timescales for approval of a therapy to market. One way to achieve this is to conduct detailed characterization studies using a miniature model, such as a bioreactor or a single-use micro-well plate system, in order to identify the key parameters which have an impact on the scale-up of a bioprocess. The design and development of such a representative miniature model, using integrated sensors for monitoring of process conditions on-line, is vital for scaling purposes and allows for parallelization and automation whereby multiple parameters can be tested in a high-throughput fashion.