NIIMBL’s Viral Vector Program has selected eight teams to participate in an interlaboratory study focused on improving the accuracy of AAV9 capsid titer measurements. The goal is to enhance consistency in manufacture of gene therapy products.
The selected teams are:
- Carnegie Mellon University
- Keck Graduate Institute
- Landmark Bio
- Michigan Technological University
- MilliporeSigma
- North Carolina State University
- PATH Center for Vaccine Innovation & Access
- University of Delaware
Each team will evaluate United States Pharmacopeia’s (USP) new AAV9 reference material to assess its suitability as a universal calibrant.
Capsid titer measurement is a vital part of gene therapy manufacturing. These measurements affect product potency, dosing accuracy, and process optimization. However, the industry lacks a reliable, standardized method for measuring capsid titer. Current commercial ELISA kits and calibrants yield highly variable results, leading to poor reproducibility across laboratories and limiting data comparability in collaborations, submissions, and cross-project analysis.
By assessing USP’s AAV9 reference material, the study aims to strengthen analytical alignment across the industry and bolster regulatory confidence in gene therapy manufacturing processes, ultimately benefiting patients.
“Controlling for total viral load, especially in high dose therapeutics, is critical for the patient’s safety when administering in vitro gene therapies. Establishing a more consistent and reliable measurement of total viral capsids will help sponsors to develop processes that mitigate the associated risks. In the long term, this should translate into better patient outcomes overall.” said Chris Williams, NIIMBL Viral Vector Program Lead.
The study began in June and is expected to last approximately six months.
NIIMBL’s Viral Vector Manufacturing and Analytics Program addresses cost, time, and skill barriers in the way of sustainable development of AAV-based gene therapies for prevalent indications and ultra-rare diseases. Learn more about the Viral Vector Program here.
The interlaboratory study is one example of the work being done across the NIIMBL community to drive innovation in biopharmaceutical manufacturing. Learn more about NIIMBL’s portfolio of projects here.