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.
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.
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.
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.