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Critical Challenges and Solutions for Viral Vector Manufacturing – Introduction and Upstream Process
Gene therapy is an evolving field with the potential to treat and cure diseases by modifying genes within a person’s cells. It has shown promise in various areas, including inherited disorders and cancer. However, viral vector manufacturing, a crucial part of gene therapy, poses significant challenges. Somatic gene therapy, which focuses on modifying non-reproductive cells, is more commonly used due to ethical and safety concerns surrounding germline therapy. Viral vectors, such as AAVs and LVs, are often employed to deliver genetic material into cells. The manufacturing process for viral vectors is complex and consists of genetic development, upstream and downstream production, and fill-and-finish stages. Each stage presents its own challenges. This paper aims to explore the viral vector production process, highlight critical challenges, and provide solutions to facilitate the successful translation of gene therapies from research to commercialization.