DNA vaccine manufacture: scale and quality.

The demand for plasmid DNA in large quantities at high purity and concentration is expected to escalate as more DNA vaccines are entering clinical trial status and becoming closer to market approval. This review outlines different methods for DNA vaccine manufacture and discusses the challenges that hinder large-scale production. Current technologies are summarized, focusing on novel approaches that have the potential to address downstream bottlenecks and adaptability for large-scale application. Product quality in terms of supercoiled percentage and impurity levels are compared at the different production levels.