Key Issues in the Process Development of Purification Procedures for Viral Vector and Plasmid Biopharmaceuticals

This is the authors' abstract. We don't add key points for this paper.

With the advent of the first gene therapy product to market, the industry faces the challenge of mass-producing high-purity viral particles and plasmids. The concept of manufacturing therapeutic genes rather than therapeutic proteins as marketable products is still in its infancy. Although manufacturers of biopharmaceuticals have decades of experience in the purification of proteins, virus and plasmid products pose unique challenges that cannot be addressed without some modifications to traditional, protein-based approaches.