Voyager will transfer its research and development production capabilities to the contract development and manufacturing organizations (CDMOs), which will support the development of its gene therapy programs, providing late-stage clinical and commercial-scale capabilities.
Voyager will lead early-stage development and scale-up before transferring the technology. The company’s manufacturing platform uses a baculovirus/Sf9 cell production process to produce clinical and commercial scale batches of adeno-associated virus (AAV) vectors.
The length of the collaboration has not specifically been disclosed, though it could be renewed based on meeting set milestones and other criteria, a spokesperson told us.
"Voyager plans to use [the CDMOs] to support the clinical development of its programs and if its programs are approved, for commercial supply," they added.
In line with the collaboration announcement, Voyager will partner with Brammer to implement a commercial-ready manufacturing process under current good manufacturing practice (cGMP) at its Cambridge facility. At this facility and others, Brammer recently has completed a series of expansions as part of its three-year, $200m investment program.
Voyager also will partner with Fujifilm to provide first-in-human (FIH) cGMP clinical trial material production capacity at the CDMO’s College Station facility in Texas.