Voyager Therapeutics, a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, has entered into collaborations with Brammer Bio (Brammer) and Fujifilm Diosynth Biotechnologies (Fujifilm) 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.
“Collaborating with Brammer and Fujifilm fits squarely within our manufacturing strategy to build strong internal preclinical and clinical processes, analytical development, and scale-up expertise and to partner with quality CDMOs for larger scale, redundant supply and commercial-stage capacity,” said Luis Maranga, Ph.D., chief technical operations officer at Voyager Therapeutics. “Brammer and Fujifilm have recently completed renovations and launches of late-stage and commercial-ready facilities for gene therapy products in Cambridge, Massachusetts and College Station, Texas, respectively, and we are ready to begin working with them to support the advancement of our pipeline programs.”
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 today’s announcement, Voyager will partner with Brammer to implement a commercial-ready manufacturing process under current good manufacturing practice (cGMP) at their Cambridgefacility, and will partner with Fujifilm to provide first-in-human cGMP clinical trial material production capacity at their College Station facility.
"Today’s announcement with Voyager represents a continued commitment to our vision to enable innovators to bring advanced medicines to patients," said Mark Bamforth, president and chief executive officer of Brammer. "Our recently announced progress on a three-year, $200 million investment program to establish over 30 suites for clinical and commercial viral vector supply in Alachua, Florida, and Cambridge and Lexington, Massachusetts, by 2019, uniquely positions Brammer to support the dramatic anticipated growth of the gene and cell therapy sector, including Voyager’s pipeline of AAV gene therapy programs."
“We are thrilled to begin working with Voyager and to be a contributor to the development of their gene therapy pipeline,” said Gerry Farrell, chief operating officer of Fujifilm Diosynth Biotechnologies, Texas. “These therapies have the potential of transforming patients’ lives and, as an organization, we are delighted to support our partners as they advance tomorrow’s medicines.”