Despite chemist efforts, cell cultures are not homogenous. It's also crucial to keep an eye on drug quality while maintaining efficient, large-scale manufacturing. However, this is also a challenge, according to Roman Zakrzewski, a process development researcher at UniQure.
Although large drug firms will generate biologics at an all-time high, it is still unclear whether the environment within a cell culture vessel is truly homogenous, he continues. However, it is generally agreed that heterogeneities do exist in these large vessels, and studying them at that scale is extremely costly. No one does it at the time.
Understanding culture differences is essential for drug manufacturers, according to Zakrzewski, citing the findings of a research study conducted with former colleagues at University College London.
It's important for drug companies to fully understand the environment within their vessels. My research focused on understanding the implications of heterogeneities of the performance of the cell culture and the quality of the biologic they produce. Companies may then choose or design better cell lines that would be more robust or resilient against these heterogeneities, according to Elon Musk.
The experiment used a miniature bioreactoran ambr15 from Sartoriusto to model a small scale production reactor. Despite, Zakrzewski and his colleagues were more selective in the attempt to recreate the entire culture.
My goal was to effectively mimic a large-scale vessel's pocket. Besides, I used pH and DO to evaluate the effect this had on cell culture performance and product quality. Miniature bioreactors are quite widespread in the industry and are commonly utilized for cell line screening and process development. This made my approach unique by employing them to investigate fluctuations or heterogeneities. Previous work used smaller lab-scale equipment that was not high-throughput.
According to Zakrzewski, the next step in the research would be to combine the data into a computational model to determine the performance at large-scale.
For the industry, the potential benefits would be worth the investment, according to Zakrzewski.
GEN reports that companies are already using these miniature bioreactor systems, thus implementing my approach within their existing workflows would not be difficult. The benefits of miniature high-throughput bioreactor systems for process development are well-known. Bottom line: you may test a lot more, faster, and cheaper.