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The program will improve access to adeno-associated virus gene therapy vectors.
On Oct. 10, 2023, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced the launch of the Viral Vectors NIIMBL-led program. The program will be focused on developing available, economically viable manufacturing processes and analytical platforms for adeno-associated virus (AAV) gene therapy vectors. NIIMBL hopes the program will provide access to high-quality viral vectors without cost or speed limitations.
The program will include a process workstream with shared access to an AAV process platform for rare diseases and advanced process performance. It will also include an analytical workstream to enhance access and utility of an AAV analytical toolkit and reference resources. A parallel initiative in workforce development for AAV vector manufacturing and analytics will also enhance the program by educating and training personnel. “Advancing the industry is not just about creating new technology and making it available; you need the people and knowledge to apply that technology most effectively,” said Eric Hacherl, Viral Vector Program co-lead, in a press release. “Our hope is that as the technology is developed, we will have sufficient training resources in place and be able to establish a capable and confident workforce, ensuring there is no delay in technology adoption.”
“There are thousands of rare diseases, many of which could be candidates for AAV-based gene therapy. Collectively advancing and converging around core manufacturing and analytical technologies so we can avoid redundant work and consistently achieve better outcomes is fundamental to bringing more therapies to more patients faster,” said Guangping Gao, PhD, member of the NIIMBL-led Viral Vector Program Steering Committee and gene therapy pioneer from the University of Massachusetts Chan Medical School, in the press release.
“We have assembled an initial steering team of thought leaders and subject matter experts over the past year and have identified two key workstreams to kick-off this program. Time is our biggest motivator, and we know that moving quickly is essential to ensuring these advances remain relevant to the treatment needs of patients,” said Tim Charlebois, Viral Vector Program co-lead, in the release.