P24: Development of an automated scale-down bioreactor system for rapid process optimisation

The competitive nature of the industrial biotechnology and biopharmaceutical market means that tools to reduce time to market for new products can give significant competitive edge.  Two key activities that must be undertaken early in development for candidate products are cell line selection and process optimisation, which can be both time consuming and costly. It is therefore important that the final outcome is a cell line and process that is both robust and can be efficiently transferred to manufacturing scale.  To ensure this is achieved the scale-down model that is implemented during research and development should mimic the manufacturing process; use low volumes to reduce materials cost but are sufficient for detailed offline analysis; and require minimal user interaction.  To address these issues TAP Biosystems have developed the ambr250™, an automated, miniature bioreactor (250 mL working volume) system that can operate 24 single-use bioreactors in parallel.  The bioreactor is designed to enable highly parallel process development and strain/cell line screening in a model mimicking large-scale bioreactors, whilst also achieving a rapid turnaround (less than 24 hrs) between fermentations. This core technology combined with 24 fully controlled bioreactor stations; automated feeding and sampling; and offgas analysis for each bioreactor provides a powerful tool for early stage process development providing relevant information for large-scale manufacturing, whilst reducing the space and resources required to operate 24 bioreactors. Here we present data taken from engineering investigations and both cell culture and microbial fermentation studies by a number of industrial users conducted using the system.