S21: Delivering Industrial Biotech Products to Next Generation Cell Therapies using Design of Experiments (DoE), Quality by Design (QbD) and Scale-up/Scale-Down Tools-Microbioreactors

Industrial and biopharmaceutical organizations must reduce timelines and manage ever-shrinking resources to successfully meet deadlines for commercial product launches.  Today’s organizations are not just developing products using one expression platform but many, for example, bacteria, yeast, CHO, fungi and even stem cells. It is beneficial to have a controlled scale-up/scale-down tool that is flexible enough to be used to explore and develop a variety of expression platforms. DoE experiments are often used to define the multivariate design space of the fermentation processes and this is done with greater efficiency using high-throughput bioreactors, such as the Micro-24 Microbioreactor, which exemplify the principles of QbD.  Tools, methods, and concepts that have historically been reserved for either Microbial or mammalian applications are now being used for either and both groups are benefitting.

A scale-up/scale-down study for a microbial biopharmaceutical process will be presented which will consist of industrial and small scale fermentor data. The data will show the importance of identifying critical parameters early in development and then having the confidence in the models to scale up those findings. Examples of rapid cell line selection and development will be presented where consumables/vessels reserved for mammalian applications were used to deliver microbial processes using the Micro-24 hardware. Microbial and mammalian fermentation practices such as “high-throughput” bioreactors are impacting the way cell therapies are being developed and “optimized” and data will be presented showing the benefits running controlled throughout the development process. Finally, enhanced software for the Micro-24 Microbioreactor will be introduced and …….