DNA vaccine manufacture: scale and quality

Abstract

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.

Keywords::

• DNA vaccine
• manufacture
• plasmid
• quality
• scale
• supercoiled percentage

Acknowledgements

The authors would like to thank Angela M Bodles-Brakhop for her assistance with the editorial review of the manuscript.

Financial & competing interests disclosure

Henry Hebel and Stephen Rodriguez are employees of VGXI, Inc. Henry Hebel is an inventor on patents and patent applications assigned or licensed to Advisys, Inc. Ying Cai is an employee of VGX Pharmaceuticals, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.