In this current state, upstream process development is extremely resource intensive. It is a long and costly road from cell line development to scale-up and GMP manufacturing, and it is largely wet-lab experiment based. Each of these experiments result in a large amount of heterogeneous data stored in different places and formats. Generally, once this is all put together, it is only factored into decision-making through data-driven modeling.
The challenge with this methodology is that the biology of the system is not fully understood, which can be attributed to and lead to variability and non-reproducibility in processes. With pressure to adopt continuous processes and novel therapeutics, it is challenging to apply the learnings from more traditional bioprocesses to these new modalities. Additionally, standard workflows do not yet exist.
Here, we explore opportunities for improvement in upstream processing along with potential solutions to the challenges associated with current approaches. One such solution is Cell Insights by Umetrics® Studio, which is an in-silico simulation application for upstream bioprocesses.