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.