Our rAAV Manufacturing Process

Avirmax uses an internal cGMP facility for manufacturing clinical material to support its preclinical and clinical programs. Our production system is based on the Bac-to-AAV technology which was initially invented by our co-founder, Dr. Haifeng Chen. It utilizes the engineered artificial intron consisting of insect promoter in both the AAV rep and cap sequences, coupled with versatile baculovirus expression system and the suspension insect culture to dramatically enhance the stability of recombinant baculoviruses, the infectivity of AAV vectors, and the AAV production yield that reaches as high as 1e+15 vg/L.

The Bac-to-AAV technology has been utilized by numerous gene therapy companies to produce clinical material for clinical development at early and late phases in the industry.

Avirmax has developed a robust, simple and cost-effective manufacturing technologies for fast production of high quality and titer rAAV stocks using Sf9 cell system. We can achieve a productivity of 1e+15 to 1e+17 vg/batch within about two months from a plasmid DNA of GOI and defined serotype of vector capsid. This process is easy to be scaled up for large scale production for late phase development and commercial launch.

The Sf9 cell culture provides higher pathogen safety assurance for gene therapy products than those manufactured using human or other mammalian cell culture systems (i.e. HEK293, HeLa-3 cells). Sf9 cell culture hardly supports mammalian virus prorogation and it is operated under BSL-1 biological safety environment during production of the recombinant protein (i.e. monoclonal antibodies) using CHO or BHK cells.