A surfacing trend in the industry is the interest in continuous bioprocessing. The continuous system makes an attractive option to increase the throughput of the plant allowing manufacture of large amounts of product in a facility with a flexible platform of smaller scale bioreactors. The challenges of the biotech industry offer opportunities to spur innovations in process development. Many biologics manufacturers successfully transition from batch processing to continuous processing to maximize flexibility and minimize the cost of goods (COGs), benefiting from standardization, simplified scale-up, and more consistent product quality. An integrated continuous biomanufacturing (ICB) platform has an advantage over conventional approaches, because of its reduced volumes and footprint, and no scale-up is required between development and manufacturing. Both mAb and non-mAb manufacturing-process architectures could converge in the future and be consolidated within the same facility, offering even greater flexibility and savings. At the same time, these platforms usually deploy a combination of single-use bioreactors that are assembled in a modular fashion and can feed simultaneously and timely into the same train. In fact, platform continuity, clarification built-in operational design, 10-15 fold higher cell densities, and easy logistics due to integration add up for an overall bioprocessing intensification. These kinds of setting converge with emerging tools to deliver a streamlined, high throughput, highly automated, pipeline that is easy to operate.
Furthermore, with the achievement of titers exceeding 2 g/L at the 6-L scale, it is now becoming feasible to produce material rapidly for pharmacology, formulation, and toxicology studies without having to establish a stable cell line. Which are possible thanks to higher-stringency selection by using CHO host cells that have a knockout in the GS or DHFR or incorporate chromosomal architectural sequences, such as ubiquitous chromatin opening elements (UCOE) or matrix attachment regions (MARS) into an expression plasmid.
This article is an excerpt from our recent whitepaper “Bioprocessing Cell Acceleration and Optimization“. The paper discusses how to streamline development and production of cell culture acceleration and optimization. Access the complete whitepaper here.