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The process of building a cell or gene therapy can be long and complex, with substantial challenges encountered on the road to regulatory approval. A drug developer can enhance their chance of success, however, with their early scientific and strategic decisions. These important early decisions can include:
- Choice of plasmid system, regarding viral vector yield, safety profiles, and intellectual property freedoms
- Early investment in early preclinical plasmid engineering to optimize genetic elements, minimizing any configuration changes after early efficacy studies
- Investment in preclinical process development to further enhance a viral vector production workflow ahead of GMP manufacturing
In this GEN webinar, our guest presenters will discuss how establishing an early partnership with a CDMO for both plasmid and viral vector manufacture throughout the whole therapeutic journey can enhance long-term success. Moreover, our discussion will focus on how end-to-end partnerships with a fully integrated CDMO can also ensure that all requirements are covered from early discovery stages through to commercial GMP manufacture and regulatory submission.
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.
Webinar produced with support from:
Group Leader, Plasmid Engineering and Production
OXGENE
Group Leader, Process Development
OXGENE
