A company's development approach is dictated by its business model. Startups use simple, low-cost methods for quick proof-of-concept data. Large pharma invests in robust, high-throughput systems to de-risk processes for regulatory demands. CDMOs must be flexible to serve both.
A common error is screening strains or media in a simple batch mode when the final process will be fed-batch. This mismatch leads to incorrect candidate ranking and selection, forcing teams to restart the development process once the error becomes apparent during scale-up.
In early microbial cultivation R&D, focusing on whether a system is 'stirred or shaken' is a distraction. The most critical parameter for success is the amount of oxygen introduced (KLa and oxygen transfer rate), not the mechanical method of delivery.
Failing to conduct comprehensive screening for strain selection and media development at the project's start creates issues that become significantly more difficult and expensive to resolve later. Small, early-stage problems can derail downstream processing and scale-up efforts entirely.