NEWARK, Del., August 10, 2023 — The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is pleased to announce a Request for Information (RFI) related to a planned method development study, focused on the development and optimization of Next-Generation Sequencing (NGS) methods for extended characterization of Adeno-Associated Virus (AAV) gene therapy vectors.
The planned study aims to promote collaboration among multiple laboratories and industry partners to enhance the reliability, consistency, and understanding of AAV vector properties using NGS-based analysis methods. The objectives for this study are method development, sharing of best practices, and the establishment of a common protocol among the project teams. Depending upon the study outcome, subsequent stages would be planned in the future.
“As NIIMBL prepares for the launch of the Viral Vector (VV) Program, this study will be significant in developing a robust and reproducible NGS-based AAV characterization method for use within the Program. This RFI is a key step in developing additional opportunities for our community to engage with our industry-leading VV Program,” says Tim Charlebois, NIIMBL Senior Fellow and VV Program lead.
RFI submissions will be reviewed by the VV Program Steering Team. NIIMBL expects to release a Request for Application (RFA) based on capabilities assessments from the RFI2023.1 responses. This RFI is not a solicitation for funding.
The deadline for submissions to the RFI is September 5, 2023. For key dates, important information, and how to apply, go to the NGS Interlaboratory Study RFI page.
To learn more about NIIMBL, including how to be a member, visit NIIMBL.org.
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