Are there any vaccine targets that you would not want to manufacture using single-use systems maybe a highly infectious/toxic target or some other factor? Are there any special conditions that should be considered?

Answer

Application of single-use technology does not relieve the process owner from assessing any and all appropriate risks. The infectiousness or toxicity of a process, process intermediate or end-product should be considered, with operator safety being paramount. Unlike stainless steel fermentors, single-use fermentors rely on plastic films, tubing, etc. There are risks, though low, of breaches in the integrity of the film or tubing or failures due to miss use.