Latest Developments in Viral and Non-Viral Vector Manufacturing

Guest Editor - Dr Nathalie Clement, University of Florida, USA

As cell and gene therapies move towards the clinic, critical developments in the production of viral vectors are required to enable large-scale manufacturing and distribution. A balanced overview of the merits and challenges of the different vector types (viral and non-viral) is provided; complemented by a discussion of the key manufacturing considerations to enable large-scale, quality-assured vectors for clinical use including culture systems and their impact on vector productivity:

  • Critical issues for the scalable manufacture of AAV and Lentiviral vectors including process changes, drug product comparability, pre-clinical and clinical data requirements and the associated regulatory implications.
  • Novel approaches to improve the vector yield using different cells, viruses and technology platforms.
  • Balancing the need to drive down cost of goods with the challenge of creating stable cell lines for scaleable vector production.
  • Latest advances in the development of non-viral vectors – implications for manufacturing and scalability.