One-Bac 4.0 system is an insect/baculovirus system for AAV production. The production process consists of several key parts: baculovirus plasmid construction, seed virus production, seed virus amplification, seed virus infection of insect cells, and AAV harvest. This system achieves linear amplification of production by infecting insect cells with baculovirus containing the AAV genome, overcoming the bottleneck of large-scale AAV preparation. One-Bac 4.0 system has the potential to benefit more patients due to its high yield compared to other AAV production systems.
Genevoyager is equipped with a one-stop gene therapy CDMO platform, alongsidean experienced GMP quality control teamwithexpertise inmethodology development, validation/verification, and testing toensure the high quality of our products.The routine quality release tests and methods are outlined below.
The One-Bac 4.0-derived AAVs maintain high yields both before and after purification at a production scale of 50L.
The Baculovirus Expression Vector (BEV) employed in the One-Bac 4.0 system maintains high stability for multiple passages, ensuring consistent high yield and infectious activity of AAV batches during large-scale production.
The One-Bac 4.0 system achieves an impressive full capsid ratio of over 90% in its final product.
Results from cell and animal experiments demonstrate that One-Bac 4.0-derived AAV exhibits equivalent or higher infectivity compared to HEK293 AAV.