How would you recommend testing scale up conditions prior to moving to the single use bioreactor? Are there any differences to be aware of between using single use and stainless steel?

Answer

Simulated process modeling, using current known process data typically provides the necessary feasibility information. About the technologies, for processes that are transferable, single-use offers an equivalent platform to stainless. There may be unique processes not suited for single-use. Media and additives cannot be sterilized in the bag, but rather externally. Consider your motivation for implementing single-use fermentor technology. Outline your process and go through it, on paper, to maximize your success. Planning and preparation is crucial, especially considering how quickly a system can be turned around. Single-use fermentors can play an essential role in modern-day process environments…development and production.