NEWARK, Del., October 10, 2023 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) officially launches the Viral Vectors NIIMBL-led Program focused on developing and making broadly available robust, economically viable, shared manufacturing process and analytical platforms for Adeno-Associated Virus (AAV) gene therapy vectors. NIIMBL has committed to this effort with an ultimate vision to provide access to high quality viral vectors capable of serving the full spectrum of patient need, from prevalent indications to ultra-rare diseases, without cost or speed limitations.
“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, Ph.D., member of the NIIMBL-led Viral Vector Program Steering Committee and gene therapy pioneer from the University of Massachusetts Chan Medical School.
As a consortium connecting over 200 industry, academia, government, and non-profit members in the biopharmaceutical manufacturing community, the NIIMBL ecosystem allows new technologies to advance faster. Viral Vectors is one of several NIIMBL-led programs carefully selected after extensive discussion and road mapping with subject matter experts around the world.
“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,” shares Tim Charlebois, Viral Vector Program Co-Lead.
The initial structure of the Viral Vector Program will include:
1. Process Workstream
- Shared-Access AAV Process Platform for Rare Diseases
- Advancing AAV Process Performance
2. Analytical Workstream
- Enhancing Access and Utility of AAV Analytical Toolkit
- AAV Reference Resources
Additionally, a key component of the Viral Vector Program includes a parallel initiative in workforce development for key capabilities in AAV vector manufacturing and analytics. “This initiative is designed to educate and train talented individuals to operate the suite of technologies that will result from this program. 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. “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.”
NIIMBL will be hosting a webinar on the Viral Vector program on November 15, 2023. To register for the webinar and to learn more about NIIMBL and the Viral Vector program, visit NIIMBL.org/ViralVector.
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.
Maria X. Chacon
Director of Marketing and Communications