Regulatory Focus™ > News Articles > 2021 > 7 > USP, NIST and NIIMBL collaborate to boost viral vector quality standards

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Posted 29 July 2021 | By Joanne S. Eglovitch 

USP, NIST and NIIMBL collaborate to boost viral vector quality standards

A new public-private collaborative among the United States Pharmacopeia (USP), the US Department of Commerce’s National Institute of Standards and Technology (NIST) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) pools the expertise or the organizations to develop better measurement tools to assess the quality of adeno-associated virus (AAV), an increasingly important vector for gene therapy delivery.
According to a 27 June announcement, AAV-based therapies are used to treat a type of inherited retinal dystrophy that causes blindness, and to treat spinal muscular atrophy in children, with many more applications in the development pipeline.
The collaborative will seek to develop tools that will allow better assessment of quality attributes of AAVs, such as purity and the proportion of virus particles that carry the genetic “payload” needed to achieve therapeutic effect.  
To improve inter-rater reliability in AAV quality assessment, USP and NIST have multiple laboratories measure vector quality over a 2-to-3-year period. The subsequent analysis is expected to boost consistency in AAV quality measurement.  
“This work will help build the trust in the quality of the AAV,” said NIST research scientist and chemical engineer Wyatt Vreeland. “And it will support the development of promising new gene therapies that will greatly improve peoples’ lives.”
Fouad Atouf, USP’s vice president for global biologics, said that both parties will contribute in different ways. “NIST’s long-standing experience with measurement sciences and USP’s established role in the application of measurement to the development of methods and associated reference standards is a great combination to advance the field of testing biopharmaceuticals.”
NIIMBL is a public-private partnership whose mission is to accelerate biopharmaceutical innovation and is funded through a cooperative agreement with NIST.
NIIMBL announcement


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Tags: gene, NIIMBL, NIST, therapy

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