Title : Scale up for manufacturing next generation probiotics: Process development strategies and processes to fast track products into the market
Abstract:
Next Generation Probiotics, such as Akkermansia muciniphila, Faecalibacterium prausnitzii, Christensenella minuta and Veillonella, are a new market for the probiotics in many innovative markets. As most of the next generation probiotics are obligate anaerobes the existing system for the development, manufacturing and capsulation technologies of probiotics cannot always been transferred across.
Process development is a critical step in the pathway to take a strain from discovery to market following the discovery phase. It is often the step where decisions are made on the whether to progress the product to scale up and manufacturing and generation of material for preclinical studies. Some of the critical parameters are robustness, productivity and stability of the process. Sacco System Australia has recently established to provide this service for next generation probiotics and Live Biotherapeutics. Some examples of development approaches and scale up issues will be presented, focusing on the bioprocessing impacts and outcomes.
Examples of the use of high throughput screening using a 96 well plate system, optimisation at 1L and scale up to 30L production will be presented, all conducted under anaerobic conditions. Application of different methods of media sterilisation will be reviewed and the use of small-scale discontinuous centrifugation for cell recovery will be discussed. Finally approaches for lyophilisation development will be discussed with focus on stability of the product under different temperatures and oxygen conditions.
