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Project A-Gene is a part of the NIIMBL Biopharma Consortium, a multi-partner collaboration of government, industry and academia that leverages the expertise of engineers, scientists, product and process designers, and business owners to support the development and commercialization of advanced manufacturing technologies to support the production of biopharmaceuticals, including biopharmaceuticals, cell and gene therapies. The consortium is funded by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Health.
The data for Project A-Gene comes from a primary study of viral vector manufacturing, including the packaging and purification process, and a follow-up data analysis conducted by NIIMBL researchers. By integrating QbD into the process, the study shows that the manufacturing team reduced the overall time and number of required adjustments during production. The data also showed that adjustments were performed only when necessary, leading to reduced cost and quality risk.
Founded in 2001, NIIMBL is the U.S. public-private partnership dedicated to supporting the development and commercialization of advanced manufacturing technologies to support the production of biologics, including biopharmaceuticals, cell and gene therapy products.
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