Traditionally, technologies such as shake flasks or spinner flasks have been used for strain/cell line screening, medium design, and process development. However this approach is manually intensive and has a high operating cost and requires a large laboratory.
A well understood biologics manufacturing process is best developed by the application of complex DoE (design of experiment) methodologies. Such methodologies have a very high experimental burden. All areas of the process must be fully understood, including media components and all process parameters (and the effects of changing them), because such factors alter both titers and product quality attributes.
Because of the inherent problems associated with traditional technologies, the resulting data can include a number of errors that require constant experimental iterations. Such issues lead to costs that are prohibitive to the development of many bioprocessing strategies.
Well-characterized and accelerated process development and optimization can be achieved only if the process can be sufficiently automated in a parallel miniaturized platform that is both easy to set up, scalable, and compatible with disposable technologies. So there is a need to move away from traditional bioprocess equipment and into a platform that enables high-throughput process development and optimization. That type of technology should have three key characteristics:
- • miniaturization to enable faster experimental throughput at a low cost
- • automation for accurate, reproducible performance of a large number of individual operations
- • parallel processing to allow evaluation of a wide experimental space, resulting in process understanding.
The automated mini bioreactor technology that allows for high-throughput process development for both microbial fermentations and cell culture processes