Expands AAV Manufacturing Capacity to Support the Growing Clinical Applications of Gene Therapy
This large-scale production of rAAV employs embryonated avian eggs to stably package and produce adeno associated viral (AAV) vectors. A powerful research and clinical tool, AAVs deliver genetic material to specific cells and provide in vivo long-term gene expression. Available manufacturing processes are expensive and unable to meet the demand for large quantities of high quality AAVs needed for clinical trials. Though common in vaccine production, the gene therapy industry has not previously attempted to use embryonated avian eggs to package and propagate recombinant AAV.
Researchers at the University of Florida developed a technique to produce AAVs in larger quantities by using embryonated avian eggs as the host vehicles. This technique is cost-effective, compatible with process regulations for current Good Manufacturing Practice, adaptable to existing machinery and methods of vaccines, and more scalable than other viral vector production processes.
Application
Cost-effective, large-scale production of recombinant AAV using embryonated avian eggs
Advantages
- Increases manufacturing yields of AAV, improving scale to meet demands for gene therapy applications
- Less costly and time consuming , making it a more viable option for producing AAV vectors
- Meets the needs for preclinical studies and clinical trials as well as the strict quality standards of the FDA
Technology
This technique to produce AAV vectors within embryonated avian eggs involves transfection of a single plasmid that comprises all genes necessary for efficient packaging. AAV vector growth in embryonated avian eggs can provide large scale manufacturing capacity similar to what vaccine industries achieve. The technique works with any AAV serotype and transgene packages for creating rAAV particles, and it is compatible with process regulations required for manufacturing clinical compounds.
Brochure
