4. Bioprocessing 4.0
Another tool that increases efficiency and helps companies keep an edge in this competitive landscape is the concept of Bioprocessing 4.0, said the Sartorius team.
"This approach uses digitization to give biopharmaceutical companies the flexibility needed to adjust process parameters quickly and easily while maintaining quality and reducing time and costs. It improves workflows in several ways: it improves downstream processes, thereby shortening process development cycles and accelerating time to market; it increases product titers and yields; and it enhances product quality and similarity," said Gupta and Boulais.
As time goes on, the industry is continuing to adopt tools and technologies that allow it to connect all of their equipment within a workflow digitally, from end to end. In addition, manufacturers are incorporating sophisticated feedback loops and machine learning to continuously optimize their workflows along the way. This approach increases the speed of production, they said.
Bioprocessing 4.0 can be implemented through a number of pathways. "Companies can begin, for example, by acquiring products such as fully automated, upstream single-use bioreactors. These bioreactors introduce flexibility into workflows by using high cell density fed-batch cultures or perfusion cultures, which facilitates rapid production. These bioreactors also feature single-use in-line sensors that report data in real-time, helping scientists measure Critical Quality Attributes (CQAs) and make modifications to the workflow to improve it," said the Sartorius team.
Finally, scientists can improve their process controls even further by replicating their bioprocesses digitally and running simulations. This method for optimization can shave weeks off manufacturing timelines. It can also reduce the downtime associated with testing data off-line and cleaning equipment, they noted.