Manufacturing

The ability to produce and manufacture high-quality AAV vectors at scale is a critical success factor in AAV gene therapy.

Several members of Voyager Therapeutics’ current production team invented and developed the baculovirus AAV production system, a technology for producing AAV vectors at scale in insect-derived cells, which we use and have continued to improve. This system has a number of attributes including high yields, high purity and scalability.

An enhanced platform has been developed for increased productivity and product recovery. A single manufacturing run at 500-liter scale can yield many thousands of doses of an AAV gene therapy.

A relatively high percentage of AAV vectors contain the therapeutic DNA, reducing the number of empty capsids compared to alternative manufacturing approaches. In addition, the baculovirus system eliminates the potential of risk of introducing mammalian cell-derived impurities and replication competent vectors.

This process is reproducible at volumes ranging from 0.02 liters to 500 liters in single-use bioreactors. The lower levels of empty capsids produced in our enhanced platform enables all downstream purification steps to be scalable and removes bottle-necks present in other manufacturing methods.

We are building a state-of-the-art process research and development production facility for manufacturing research-grade AAV vectors onsite at our Cambridge, Mass. headquarters and a cGMP, commercial-scale AAV manufacturing capability through our collaboration with MassBiologics, in Fall River, Mass., both of which employ our baculovirus production system. We have also established a contract manufacturing relationship with other companies specializing in the manufacture of gene therapy and AAV vectors.