Date: 2018-11-29
Type of information: Production agreement
Compound: AAV-based gene therapies
Company: Voyager Therapeutics (USA-MA) Brammer Bio (USA - CA) Fujifilm Diosynth Biotechnologies (USA - NC)
Therapeutic area:
Type agreement: production - manufacturing
Action mechanism: gene therapy
Disease:
Details: • On November 29, 2018, Voyager Therapeutics announced that it has entered into collaborations with Brammer Bio and Fujifilm Diosynth Biotechnologies to further expand Voyager’s manufacturing capabilities to support the development of its gene therapy programs. The collaborations allow Voyager to transfer its state-of-the-art research and development production capabilities to best-in-class gene therapy contract development and manufacturing organizations (CDMO) with late-stage clinical and commercial-scale capabilities, particularly as it relates to the baculovirus/Sf9 system for manufacturing adeno-associated virus (AAV) gene therapies. Voyager’s manufacturing and related intellectual property strategy focuses on developing internal processes and capabilities to produce high-yield and high-quality gene therapies, including the use of the baculovirus/Sf9 AAV production system, with the potential to transfer these capabilities to increase capacity and scale through the use of external CDMOs. As part of this announcement, Voyager will partner with Brammer to implement a commercial-ready manufacturing process under current good manufacturing practice (cGMP) at their Cambridge facility, and will partner with Fujifilm to provide first-in-human cGMP clinical trial material production capacity at their College Station facility. Voyager’s manufacturing platform utilizes a baculovirus/Sf9 cell production process that enables the production of AAV vectors at clinical and commercial scale, with the potential for increased yields over traditional production processes. Presentations at this year’s American Society for Gene and Cell Therapy (ASGCT) conference in May (link here) included data from a cleared investigational new drug (IND) application for Voyager’s VY-AADC for Parkinson’s disease demonstrating comparability between VY-AADC produced under (GMP) using Voyager’s baculovirus/Sf9 manufacturing process and VY-AADC produced using a mammalian cell system consisting of triple-transfection of human embryonic kidney (HEK293) cells. These data demonstrated that the baculovirus/Sf9 production system can be used to produce AAV vectors that are comparable with respect to bio-distribution, potency and expression in vivo compared to AAV vectors produced in mammalian cells.
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