The Approach
RVs enable genomic incorporation of new DNA into host cells, making permanent genetic changes. Compared to other gene editing tools, genomic changes made by RVs are often more permanent, stable, and do not prompt an undesired immune response in vivo. Depending on the type of RV, mitotic or post-mitotic cells can be infected.
The Challenge
Several different manufacturing methods have been used for RV expression, purification, and formulation. RVs have been manufactured from adherent HEK293, Sf9, and HeLa cells. Each expression system has unique challenges with scalability, infectivity, and quality.
Theragent offers services to help scale up your adherent retrovirus cell culture to a cost-effective suspension cell culture process.
RVs are used in gene-modified cell therapies to edit the genome of cells derived from donors or patients. Six RV-based gene therapies have garnered FDA approvals between 2017 and 2022, with three of the approvals being lentiviruses. Clinical disease targets include lymphoma, leukemia, HIV, melanoma, neurological disorders, and graft versus host disease.
No platform manufacturing methods exist for all RVs; each RV vector requires a unique manufacturing development assessment. Understanding the pros and cons of the different cell lines and manufacturing systems will help in choosing the appropriate path for each desired asset.
Theragent offers services to help scale up your adherent retrovirus cell culture to a cost-effective suspension cell culture process. Our research and development team is well-versed in HEK293 cell lines and stand ready to produce an optimized retroviral vector that meets your cell and gene therapy needs.